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LAZA MEDICAL, INC., A SHIFAMED PORTFOLIO COMPANY, CLOSES $36M IN SERIES A FINANCING

Uncategorized by Comments are Disabled

Company accelerates development of its AI-powered robotically-assisted imaging solution for cardiovascular interventions and appoints seasoned medtech executive as General Manager 
LOS GATOS, Calif., Dec. 12, 2023 /PRNewswire/ — Laza Medical, Inc., the latest Shifamed portfolio company, announced today that it has closed $36M in Series A financing. Laza Medical is developing an imaging solution for cardiac interventions enabled by artificial intelligence (AI) software and state-of-the-art robotics. Led by The Capital Partnership (TCP) with financial participation from GE HealthCare, PA MedTech VC fund, Unorthodox Ventures, and Dara Holdings, funds will be used to accelerate product development and further expand the team. Additionally, the company announced the appointment of seasoned medtech executive, Pablo Garcia, as General Manager.
“The closing of this significant financing round validates the large, unmet need Laza’s solution will address, and we are grateful for the strong support of our investors,” stated Amr Salahieh, Founder of Shifamed and Chairman of Laza Medical. “I am delighted to have Pablo join and lead Laza at this important time. His wealth of knowledge and expertise in both digital products and robotics will be critical as Laza drives towards its upcoming milestones.”
Mr. Garcia joins Laza as General Manager and brings over two decades of medical device development and leadership experience. Previously, he served as the Vice President of Digital Solutions for Johnson & Johnson and was the technical co-founder of Verb Surgical, a strategic venture between Google and Johnson & Johnson to develop a surgical robotics platform.  In 2020, this venture was acquired by Johnson & Johnson to be part of their medical robotics portfolio.
“I am excited to join the Laza team and look forward to advancing this comprehensive imaging solution so that interventional operators can safely and efficiently tackle complex cases,” stated Garcia. “We have assembled a strong team with expertise in robotics, software, artificial intelligence, and medical imaging, and are committed to bringing this much needed innovation to market.”
Structural heart and electrophysiology are two large and rapidly growing segments of the interventional cardiology market. Ultrasound imaging is necessary to guide these interventional cases, yet lack of resources makes it also a leading factor limiting growth. Laza aims to optimize procedural workflows and elevate the standard of imaging for these procedures. The company’s solution is designed to enable top-quality imaging and advanced procedure navigation for a broad population of clinicians through a simple user interface.
“Obtaining high quality images of the heart is critical to improving diagnostic confidence and guiding cardiac interventions,” said Dagfinn Saetre, General Manager, Cardiovascular Ultrasound, GE HealthCare. “We appreciate the opportunity to participate in this funding round for Laza Medical, who is working to pioneer innovative AI, robotics and ultrasound technology to help overcome some of the most pressing cardiac imaging challenges facing clinicians today.”
About Laza Medical, Inc.Laza Medical is a privately held portfolio company of Shifamed, LLC., a highly specialized medical innovation hub founded by serial entrepreneur, Amr Salahieh. The company is focused on developing a high-quality AI-powered robotic imaging solution for cardiovascular interventions. For more information, visit www.lazamedical.com.
MEDIA CONTACT:Charlene HerndonSPRIG Consulting LLC[email protected]
SOURCE Laza Medical, Inc.

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Cadrenal Therapeutics Engages The Sage Group to Advance Tecarfarin’s Late-Stage Development and Commercialization

Coronary/Structural Heart by Comments are Disabled

PONTE VEDRA, Fla., Dec. 12, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company developing tecarfarin, a late-stage, novel, oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths (due to blood clots in patients with certain orphan diseases), today announced an engagement with The Sage Group (www.sagehealthcare.com) to assist the company in exploring strategic partnerships, co-development and licensing agreements for tecarfarin.
The Sage Group is a leader in providing strategic and transactional advice to healthcare and life science companies in the pharmaceutical, diagnostics, medical devices, biotech, regenerative medicine, and cell and gene therapy fields. This partnership will give Cadrenal access to The Sage Group’s clinical and regulatory expertise, capital resources, and network of contacts, including innovators and large pharma companies.
Tecarfarin is a novel chemical entity that provides stable anticoagulation to patients with certain orphan diseases, including End-Stage Kidney Disease (ESKD) with Atrial Fibrillation (AFib); Left Ventricular Assist Devices (LVADs); and Antiphospholipid Syndrome (APS). The currently available blood thinners, including warfarin, Pradaxa, Xarelto, Eliquis, and Savaysa, fail to achieve sufficiently stable anticoagulation in these patients and are not widely prescribed for these rare medical conditions. In recent advertisements for Eliquis, the narration specifically states, ‘Don’t take Eliquis if you have an artificial heart valve…’ and ‘Eliquis is not for patients who have antiphospholipid syndrome (APS).’
Tecarfarin was designed to solve one of warfarin’s major problems, namely warfarin’s unreliable pharmacokinetic (PK) profile, due to its metabolism via the cytochrome P450 pathway. This pathway is responsible for the metabolism of many other drugs, resulting in drug-drug interactions that can lead to unstable anticoagulation. Tecarfarin was specifically designed to be metabolized via an alternate pathway, resulting in a more reliable, stable PK and anticoagulation, as evidenced in clinical trials in over 1,000 patients.
“Patients with certain orphan diseases, including ESKD with AFib, LVADs, and APS, suffer from a lack of options to achieve sufficiently stable anticoagulation,” said Quang Pham, CEO of Cadrenal. “With The Sage Group’s support, we look forward to identifying the right partner to help us advance clinical development globally in an effort to bring a much-needed blood thinner solution to the market for these underserved patients.”
Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease.
The FDA has granted tecarfarin orphan drug and fast-track designations for ESKD with AFib.  Cadrenal is also developing expanded regulatory strategies for LVAD and APS. Cadrenal estimates that in the treatment of these orphan diseases, the combined addressable market opportunity is in excess of US $2 billion per year in the U.S.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner), to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions.  Tecarfarin has orphan drug and fast-track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease, or ESKD, and atrial fibrillation, or AFib. Tecarfarin has been specifically and deliberately designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
ABOUT THE SAGE GROUP, INC.The Sage Group Inc. is a leader in the provision of strategic and transactional advice to health care companies in the pharmaceutical, diagnostics, medical device, biotechnology and life science fields.  Sage currently maintains offices in USA, Europe, Israel and Japan. Since its founding in 1994, The Sage Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions including alliances, acquisitions, divestitures, and financings with values ranging from $5 million to $500 million.
The Sage Group is an organization of experienced and successful executives who are committed to the service of the very vital and dynamic health care industry and its investors.
The range of services offered includes:
* Strategic alliances and licensing/partnering* M&A, divestment, buy- and sell- side* Global product and technology acquisition searches* Strategic assessment and planning* Due diligence, technology and molecule assessment, valuation* New ventures, interim management* Facilitating investment in R&D and/or company equity through introductions, network and brokering
The Sage Group’s Principals, each an Executive Director, have been Founders, Chairmen, Presidents, CEO’s and COO’s of a number of emerging health care companies. These Principals have also held senior level management positions in large multi-national organizations. In addition to their management backgrounds, The Sage Group’s Principals also have extensive experience in providing professional management consulting services to healthcare industry clients. All these experiences are being applied by The Sage Group to assist industry participants. For more information, please visit: www.sagehealthcare.com.
Safe Harbor StatementAny statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the partnership with The Sage Group giving Cadrenal access to its clinical and regulatory expertise, capital resources, and network of contacts, including innovators and large pharma companies, the belief that tecarfarin will provide LVAD and APS patients with stable anticoagulation, identifying a partner to help Cadrenal advance clinical development globally with The Sage Group’s support, developing expanded regulatory strategies for LVAD and APS, and the estimated addressable market opportunity in excess of $2 billion per year in the U.S.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to  advance tecarfarin within  patients with implanted medical devices for heart diseases, the ability to penetrate the U.S. market for patients with LVADs who struggle with stable anticoagulation with warfarin, the ability to advance patient care in cardiorenal diseases and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
Cadrenal Therapeutics:Matthew Szot, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
For more information about Cadrenal and partnering opportunities for tecarfarin, please contact:
Dr. Bill MasonThe Sage Group IncThe StockyardCreake Road, Syderstone  PE31 8SG  UKTel: +44 (0) 7785 950134[email protected]  
Or
Wayne PambianchiThe Sage Group Inc.24 E. Main Street, Box 5365Clinton, New Jersey 08809Phone: +1 908 2306170[email protected]  
SOURCE Cadrenal Therapeutics, Inc.

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AcelRx Pharmaceuticals Announces Publication of Study Evaluating Anticoagulation Practices for Continuous Renal Replacement Therapy in the United States

Coronary/Structural Heart by Comments are Disabled

Use of CRRT increased during COVID and remained at these higher utilization levels
Study results demonstrate challenges physicians have with heparin and citrate, the two currently available CRRT anticoagulants 
SAN MATEO, Calif., Dec. 12, 2023 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit.  The only FDA-approved anticoagulant for dialysis circuits is heparin, which has a half-life of 1-3 hours. Heparin is therefore classified as a “systemic” anticoagulant, as it circulates back into the patient from the dialysis circuit, resulting in anticoagulation of the patient, which is often dangerous. The FDA has given an Emergency Use Authorization (EUA) to citrate, which is classified as a “regional” anticoagulant, as its effect is reversed with a calcium infusion that is administered to the patient, therefore limiting its anticoagulant effect to the circuit.
The publication, entitled “Anticoagulation Practices for Continuous Renal Replacement Therapy: A Survey of Physicians from the United States,” is lead authored by Dr. David Boldt, and published in the journal Renal Failure.  Dr. Boldt is an Associate Professor at the University of California, Los Angeles School of Medicine, Critical Care Intensivist and Division Chief of Trauma and Adult Multi-Specialty Anesthesiology. In the study, a total of 150 U.S. board-certified physicians consisting of critical care medicine specialists (n=80) and nephrologists (n=70) who specialize in CRRT were surveyed by MedSurvey from November to December 2022 regarding their current CRRT anticoagulation practices.
 This study resulted in a number of key findings:

CRRT machine use increased by approximately 30% from pre-pandemic era to late 2022.
On average, physicians use heparin in the CRRT circuit for 43% of patients, with citrate being used in 28% of patients and no anticoagulation used in 29% of patients.
The top reason for use of heparin is that it is readily available, but concerns with heparin included systemic bleeding and heparin-induced thrombocytopenia, which were ranked 3.5 and 3.4 respectively, on a 1-5 scale of “not challenging” to “very challenging”.
Hypocalcemia (52% of physicians) and citrate safety (42% of physicians) were ranked as the top two reasons for not using citrate in heparin-intolerant patients. Physicians who do use citrate reported that hypocalcemia occurs in 37% of patients.
When no anticoagulation is used in the CRRT circuit, 84% of physicians stated filter clogging was a problem and almost a quarter of the physicians stated an increase in transfusions was required as a result.

Study limitations include that the study was an online survey; however, physicians had to pass eight screening questions to ensure they were board-certified in critical care medicine or nephrology, worked in an ICU, and were familiar with the protocols and logistics of CRRT use in their hospital.
“It is clear from this study that physicians in charge of CRRT at their institutions are not completely satisfied with the currently available anticoagulants, heparin and citrate, for use in the dialysis circuit,” stated Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. “Niyad as a potentially new regional anticoagulant for patients who cannot tolerate heparin could provide a meaningful improvement to the current standard of care in this field. Allowing physicians to avoid the complexities associated with citrate and reducing the number of patients who receive no anticoagulation by offering a new alternative can hopefully improve the quality of CRRT for these very fragile patients.”
Dr. Boldt states, “We really don’t have any great choices as it relates to CRRT anticoagulation, which is why I am excited about the potential approval of Niyad as a new anticoagulant option. Nafamostat’s ultra short half-life of 8 minutes and its limited systemic effect could really change how we approach anticoagulation of CRRT circuits. Heparin is fraught with potentially significant, and often life-threatening, complications such as systemic bleeding and heparin-induced thrombocytopenia, as well as heparin resistance, all of which make using heparin challenging in many patients.” Dr. Boldt continues, “While citrate avoids the risk of systemic bleeding, its complicated administration protocol, requirement for a calcium infusion, frequent testing of calcium levels, and citrate toxicity risks can lead many clinicians to avoid its use altogether.”
AcelRx provided funding to conduct the study. Some of the authors, including Dr. Boldt, are consultants for AcelRx but were not paid for their contributions to this manuscript.
About AcelRx Pharmaceuticals
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the FDA. AcelRx is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.
About Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.
Forward-looking statements
This press release contains forward-looking statements based upon AcelRx’s current expectations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “potential”, “believe”, “expect”, “expects”, “expected”, “anticipate”, “hopefully”,  “upcoming”, “may”, “will”, “enable”, “should”, “seek”, “approximately”, “intends”, “intended”, “plans”, “planned”, “planning”, “estimates”, “benefits”, or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to AcelRx’s product development activities and ongoing commercial business operations; (ii) risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for AcelRx’s commercial and developmental products and technologies; (iv) risks related to AcelRx’s liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; (v) AcelRx’s ability to retain its listing on the Nasdaq exchange; and (vi) risks relating to AcelRx’s ability to obtain regulatory approvals for its developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption “Risk Factors” and elsewhere in AcelRx’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx’s most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx’s SEC reports are available at www.acelrx.com under the “Investors” tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
For additional information about AcelRx, please visit www.acelrx.com.
This release is intended for investors only.
SOURCE AcelRx Pharmaceuticals, Inc.

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Q’Apel Medical Inc. Launches “Hippo” The New Generation Aspiration System for Stroke Thrombectomy

Neuro by Comments are Disabled

FREMONT, Calif., Dec. 12, 2023 /PRNewswire/ — Q’Apel Medical Inc. launches a new generation aspiration technology – the 072 Hippo Aspiration System, developed for patients suffering from a stroke due to a large vessel occlusion.
The recent FDA cleared stroke system, comprised of the 072 Hippo Aspiration Catheter and its Cheetah companion, represents a paradigm shift in emergent neurovascular intervention. The proprietary adaptive tip of the Hippo catheter redefines precision in clot engagement and removal, ensuring tailored performance for varying clot morphologies and sizes. This unique feature offers physicians real-time visibility and control during the critical phases of the procedure, providing insights previously unavailable. Visibility is crucial for the physician in confirming engagement with the culprit blockage, improving the odds for high first-pass success, and fewer passes, leading to better functional outcomes for stroke victims.
The adaptive tip of the Hippo catheter is complemented by the Cheetah, a flexible guiding companion designed to accelerate delivery of Hippo to the face of the clot. Together, Hippo and Cheetah create a synergistic system ensuring unparalleled speed, precision, and integration in thrombectomy procedures and is the ideal complement to Q’Apel’s market-leading Walrus Balloon Guide Catheter. 
“Our initial experience with the Hippo Aspiration System really demonstrated outstanding system performance. In my opinion, the impact of a highly visible and adaptive catheter tip is superior to other aspiration systems.  I can determine when my catheter is engaged with the clot, as I could see the tip conforming to the thrombus.  Once the thrombus was removed, the petals returned to their original state, so I knew I had success”, said Raymond Turner, MD, Endovascular Neurosurgeon at PRISMA Health, Greenville, SC. “This adaptive and visible tip aids physicians in making informed decisions in real time, that leads to a successful thrombectomy outcomes for patients”.
“When every minute during a stroke kills 2 million neurons, speed is essential. The Hippo Cheetah combination allows for expediency with a high rate of first pass recanalization rates”, commented Elad Levy, MD, MBA, Professor and Chairman of Neurosurgery, Professor of Radiology, Department of Neurosurgery, Jacobs School of Medicine & Biomedical Sciences, Buffalo, NY.
“Hippo’s ability to adapt to various clot morphologies is impressive. Regardless of angulation I can confirm engagement of the catheter on the clot, as I can now visualize this – which has never been possible before in an aspiration catheter. Paired with the Cheetah delivery tool, this was a fast and easy system to use, and has the potential to be practice-changing and cost-saving”, said Omar Tanweer, MD Director of Cerebrovascular and Endovascular Neurosurgery, Baylor College of Medicine, Houston, TX.
“The anticipation of Hippo & Cheetah for Q’Apel has been enormous, and we are thrilled with the performance we have seen in clinic in our initial sites,” said King Nelson, Q’Apel Medical’s CEO. “It’s in Q’Apel’s DNA to bring to market highly differentiated products that truly provide a meaningful advantage and benefit to physicians and their patients. The Hippo Aspiration System also grants us the ability to offer physicians a complete stroke procedure. Hippo was designed to work with our market leading Balloon Guide Catheter, Walrus, and now we can marry the benefits of Walrus and the overwhelming evidence Balloon Guide Catheters offer with the game-changing technology of Hippo”.
About Q’Apel MedicalQ’Apel Medical designs highly innovative technologies for neurovascular interventions and unmet clinical needs. Q’Apel’s portfolio comprises the Walrus Balloon Catheter System, the Armadillo 7F and 6F Access System, and now the Hippo Aspiration System with its companion, Cheetah. Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. Not anymore. By blending flow control, trackability, support, and access into one revolutionary solution, Walrus offers truly unmatched functionality. The 7F and 6F Armadillo Access Systems are dual-mode catheters and part of the SelectFlex™ Family of Neurovascular Catheters. These devices feature two distinct operational modes, allowing physicians to easily switch modes at any point during a clinical case and reducing the need for multiple catheters in challenging procedures. The new addition of the Hippo Aspiration System provides visible feedback via its adaptive radiopaque tip for physicians and provides information for the physician that is vital during the procedure. Also, the 072 Hippo Aspiration System is compatible with the Walrus Balloon Guide catheter for a complete stroke solution.
Media Contact: Jodie Fam415 244 9885
[email protected]  [email protected]www.qapelmedical.com

SOURCE Q’Apel Medical Inc.

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Haemonetics Corporation Completes Acquisition of OpSens Inc.

Financial by Comments are Disabled

BOSTON, Dec. 12, 2023 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, has completed its previously announced acquisition of OpSens Inc., a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology.
Haemonetics acquired all outstanding shares of OpSens for CAD $2.90 per share in the all-cash transaction, representing a fully diluted equity value of approximately USD $255 million at the current exchange rate. In connection with the closing of the transaction, OpSens’ common shares will cease trading in the public market and will be delisted from the Toronto Stock Exchange and withdrawn from the OTCQX.
“Expanding our Hospital portfolio with OpSens’ products creates exciting growth and diversification opportunities, while providing immediately accretive financial benefits,” said Chris Simon, Haemonetics’ President and Chief Executive Officer. “We are pleased to officially welcome OpSens to Haemonetics and look forward to driving greater access to OpSens’ essential solutions and benefits for physicians and patients throughout the world.”
OpSens offers commercially and clinically validated optical technology for use primarily in interventional cardiology. OpSens’ core products include the SavvyWire®, the world’s first and only sensor-guided 3-in-1 guidewire for TAVR procedures, that acts as a pacing and pressure monitoring wire advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients, and the OptoWire®, a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (FFR) and diastolic pressure ratio (dPR) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease. OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications. 
In conjunction with the transaction, Haemonetics increased its fiscal year 2024 GAAP revenue growth guidance range from 7 – 9% to 8 – 10% and reaffirmed all other fiscal 2024 guidance issued in its second quarter earnings release on November 2, 2023. In fiscal year 2025, Haemonetics expects OpSens to contribute $55 to $65 million in revenue, to be slightly accretive to earnings per diluted share on a GAAP basis and to contribute approximately $0.10 to $0.15 in adjusted earnings per diluted share, excluding one-time acquisition and integration-related costs.
In addition to expected immediate and longer-term financial benefits for Haemonetics, the acquisition expands the company’s Hospital business unit portfolio with innovative fiber optic sensor technology in the attractive interventional cardiology market. Haemonetics’ commercial success with its VASCADE® Vascular Closure portfolio, combined with extensive existing commercial and clinical infrastructure, will accelerate customer access to OpSens’ products.
Haemonetics financed the acquisition through a combination of cash-on-hand and a $110 million draw under its revolving credit facility. Following this acquisition, Haemonetics estimates that its net debt to EBITDA ratio, as defined in Haemonetics’ existing credit agreement, will be approximately 2.3x. Haemonetics expects to pay down the majority of the outstanding balance of the revolving credit facility within the next few months.
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements do not relate strictly to historical or current facts and may be identified by the use of words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “forecasts,” “foresees,” “potential” and other words of similar meaning in conjunction with statements regarding, among other things, (i) plans and objectives of management for the operation of Haemonetics, (ii) the anticipated financial impact of the transaction on Haemonetics’ operating results, (iii) the anticipated benefits to Haemonetics arising from the completion of the acquisition, (iv) the impact of the acquisition on Haemonetics’ business strategy and future business and operational performance, (v) the company’s estimated net debt to EBITDA ratio, as defined in Haemonetics’ existing credit agreement; (vi) the timeline to repay the revolving credit facility draw used to finance the acquisition, and (vii) the assumptions underlying or relating to any such statement. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics’ current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.
Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the failure to realize the anticipated benefits of the acquisition, Haemonetics’ ability to predict accurately the demand for products and products under development by it or OpSens and to develop strategies to successfully address relevant markets, the impact of competitive products and pricing, technical innovations that could render products marketed or under development by Haemonetics or OpSens obsolete, risks related to the use and protection of intellectual property, and the risk that using debt to finance, in part, the acquisition will increase Haemonetics’ indebtedness. These and other factors are identified and described in more detail in Haemonetics’ filings with the U.S. Securities and Exchange Commission (“SEC”). Haemonetics does not undertake to update these forward-looking statements.
Non-GAAP Financial Measures
This press release contains financial measures that are considered “non-GAAP” financial measures under applicable SEC rules and regulations. Management uses non-GAAP measures to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results. Performance targets for management are also based on certain non-GAAP financial measures. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, Haemonetics’ reported financial results prepared in accordance with U.S. GAAP. In this release, supplemental non-GAAP measures have been provided to assist investors in evaluating the expected impact of Haemonetics’ acquisition of OpSens and provide a baseline for analyzing trends in the company’s underlying businesses. We strongly encourage investors to review the company’s financial statements and publicly-filed reports in their entirety and not rely on any single financial measure.
When used in this release, adjusted earnings per diluted share excludes restructuring costs, restructuring related costs, digital transformation costs, amortization of acquired intangible assets, asset impairments, accelerated device depreciation and related costs, costs related to compliance with the European Union Medical Device Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”), integration and transaction costs, certain tax settlements and unusual or infrequent and material litigation-related charges, and the tax impact of these items. Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures to similarly titled measures used by other companies.
The company does not attempt to provide reconciliations of forward-looking adjusted earnings per diluted share guidance to the comparable GAAP measures because the combined impact and timing of recognition of certain potential charges or gains, such as restructuring costs and impairment charges, is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of the company’s financial performance.

Investor Contacts: 

Olga Guyette, Sr. Director-Investor Relations & Treasury   

David Trenk, Manager-Investor Relations

(781) 356-9763     

(203) 733-4987

[email protected]     

[email protected] 

Media Contact: 

Josh Gitelson, Director-Global Communications

(781) 356-9776

[email protected] 

SOURCE Haemonetics Corporation

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4DMedical and Imbio Merge to Create Comprehensive Cardiothoracic Image Analysis Portfolio

Radiology by Comments are Disabled

Acquisition brings complementary line of advanced analytical imaging technologyLOS ANGELES, Dec. 11, 2023 /PRNewswire/ — 4DMedical announces it has entered a binding agreement to acquire Imbio (a portfolio company of Minneapolis-based Invenshure). As the creators of groundbreaking lung imaging technologies, 4DMedical aims to revolutionize respiratory imaging and ventilation— for improved lung disease detection and management. Imbio technology complements those products perfectly, delivering quantitative and personalized imaging analysis for patients suffering from both acute and chronic diseases.
Core to both companies is a desire to improve the way lung disease is detected and subsequently managed. The acquisition aligns with 4DMedical’s growth strategy, providing physicians with a comprehensive suite of products combining structure and function in assessing lung disease, effectively “owning the lung.”
4DMedical XV Technology® current and pipeline software products provide regional quantification of lung function using existing imaging equipment, or the dedicated XV Scanner. Imbio’s fully automated technology transforms chest CT studies into rich visual maps of a patient’s lungs. Accompanying reports provide detailed data on the type and extent of abnormalities found in the images. Imbio algorithms support multiple clinical initiatives such as lung cancer screening, smoking cessation, surgical planning, and pulmonary embolism management programs—and can be used in clinical trials and academic research for numerous diseases.
Combining 4DMedical and Imbio existing technologies into a unified offering and development platform will drive respiratory health improvements around the globe. Imbio’s current portfolio provides validated and market-leading insights to highly specialized healthcare providers. By combining this toolset with 4DMedical’s novel technology and automated point-of-care radiology workflows, 4DMedical will revolutionize lung disease diagnosis by making it simultaneously more comprehensive, objective, personalized, and, most importantly, more widely available.The combined technology offering holds the potential to turn any standard Chest CT into a much broader Cardiothoracic Analysis—immediately providing functional, structural, and risk-based analysis for both lung and heart disease.4DMedical’s commercialization of XV Technology® in the US will benefit from the opportunity to be delivered into established Imbio contracts. This opens up the exciting opportunities of providing patient screening programs for chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), lung cancer and heart disease in the Australian and US markets.4DMedical Founder and CEO Dr. Andreas Fouras said, “We are extremely pleased with the acquisition of Imbio; it is a highly complementary strategic fit for 4DMedical, expanding our addressable market. Imbio’s suite of products deploy AI solutions to add quantification and visualization to lung structure from CT scans, bringing new indications to 4DMedical. The acquisition also provides additional inroads to engage with the United States Department of Veterans Affairs, boosting 4DMedical’s mission to improve healthcare for Veterans.””Imbio is very excited to join forces with 4DMedical to offer expanded capabilities and customer support. Together we can help clinicians utilize the vast quantitative information obtained from patients’ diagnostic chest images for lung pathologies to ultimately drive actionable decision-making for better patient care,” said Dave Hannes, CEO at Imbio.About ImbioImbio is a leader in artificial intelligence (AI) medical imaging solutions for chronic lung and cardiothoracic diseases. Imbio’s regulatory cleared solutions transform the way patients are discovered, diagnosed, and treated, enabling physician productivity and more personalized care for patients. For more information, please visit www.imbio.comAbout 4DMedical4DMedical Limited (ASX:4DX) is a global medical technology company that has created a step change in the capacity to accurately and quickly understand the lung function of patients with respiratory diseases.Through its flagship patented XV Technology®, 4DMedical enables physicians to understand regional airflow in the lungs and identify respiratory deficiencies earlier and with greater sensitivity as they breathe. This technology powers 4DMedical’s FDA-cleared XV Lung Ventilation Analysis Software (XV LVAS®)—the first modality to dynamically quantify ventilation throughout the lungs, and its Computed Tomography-enabled counterpart software, CT LVAS™.XV LVAS and CT LVAS reports are prepared using 4DMedical’s Software as a Service delivery model using existing hospital imaging equipment or the Company’s revolutionary XV Scanner.To learn more, please visit www.4dmedical.com.Contact:Colin Reed[email protected]SOURCE 4DMedical

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Terumo Medical Corporation’s New AZUR HydroPack™ Peripheral Coil System Provides a Soft-Packing, Long-Lasting Solution to Embolotherapy

Peripheral/Endo by Comments are Disabled

– Enhances a comprehensive platform of AZUR™ hydrogel technologies with versatile and reliable packing for embolization –
SOMERSET, N.J., Dec. 11, 2023 /PRNewswire/ — Terumo Medical Corporation is pleased to announce the launch of its new AZUR HydroPack Peripheral Coil System in the United States. The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel. It is also the only packing coil to use proprietary designed hydrogel technology to create a gel core for mechanical occlusion, a unique feature of AZUR peripheral coils.[1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.
“The AZUR HydroPack Peripheral Coil System provides optimized stability and precise delivery. Its versatility and efficiency provide interventional radiologists and vascular surgeons with an ideal solution to ensure the best possible outcome for patients,” said Chris Pearson, Executive Vice President, Terumo Interventional Systems (TIS) – North America. “Its state-of-the-art design and uniform microcatheter compatibility set it apart from other packing coils. This is important as the market for peripheral coil embolization expands and diversifies.”
The AZUR HydroPack Peripheral Coil System has a true .018″ primary wind and is available in long lengths – ranging from 5 to 60 cm – making it the longest gel core coil on the market.[1] It allows for flexible sizing and can be deployed through 2.4Fr or 2.8Fr microcatheters in a single-coil platform. With no requirements for vessel-diameter sizing other than placement of an anchor coil, this may reduce the amount of inventory required to support a wide variety of peripheral embolization procedures.[1] The soft coil design paired with an enhanced pusher allows for ease of delivery, optimized trackability and microcatheter stability.[1]
“Our unique hydrogel technology is a key differentiator as it creates a gel core and promotes new tissue growth versus the basic thrombogenic response of a traditional platinum coil. It also will allow physicians to fill open vessel space confidently and efficiently while minimizing reperfusion,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “Additionally, the tight packing and durable occlusion associated with hydrogel technology put the AZUR HydroPack Coil System in a category of its own in the peripheral coil market.”
The AZUR HydroPack Peripheral Coil System – the latest addition to the TIS embolotherapy portfolio – is designed to fill volume behind the Terumo AZUR™ CX Peripheral Coil System for vessel occlusion and to fill volume inside of the AZUR™ Framing Coil System for aneurysm occlusion. To learn more about the AZUR HydroPack Peripheral Coil System, click here: https://bit.ly/47VVAQZ.

[1] Data on file

About Terumo Interventional Systems
Terumo Interventional Systems (TIS), a division of Terumo Corporation, is a market leader in minimally invasive entry site management, lesion access, and interventional technologies. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy.  TIS combines innovative research and development with a deep market understanding to create a pipeline of industry-leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes.
About Terumo Medical Corporation
Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For over 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Health Outcomes (THO), which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices.
About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for over 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.
SOURCE Terumo Medical Corporation

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Biobeat Wearables for Enhanced Remote Patient Monitoring Partners with Best Buy Health’s Care at Home Platform, Current Health

Rhythm by Comments are Disabled

PETAH TIKVA, Israel, Dec. 11, 2023 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring (RPM) solutions for the healthcare continuum, today announced its plans to integrate with Best Buy Health’s care at home platform Current Health.
Biobeat’s wrist and chest monitors will be featured as one of the technology solutions for healthcare organizations utilizing Current Health to scale their care at home capabilities. Biobeat’s monitors continuously provide accurate patient readings of 13 health parameters, including cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, stroke volume, cardiac output, one lead ECG (only chest-monitor) and more. Data collected using Biobeat’s monitors will then integrate with Current Health, a care at home platform acquired by Best Buy in 2021, which enables care teams to monitor and manage patients at home across clinical conditions and acuity levels.
“Current Health enables healthcare organizations to personalize the delivery of healthcare at home solutions, and we are thrilled that Biobeat’s wearables will be integrated as a technology solution that is available for remote patient monitoring. This milestone will further strengthen Biobeat’s footprint with healthcare providers throughout the United States and will provide clinicians with the ability to monitor patient vital signs of patients outside of the clinical care setting,” commented Arik Ben Ishay, Co-Founder and Chief Executive Officer of Biobeat.
“Technology is a crucial component of delivering care to patients and improving their experiences and outcomes,” states Chris McGhee, CEO of Current Health. “We are excited to continuously improve our remote patient monitoring offering to make receiving care in the home a simplified experience for patients and providers.”  

About Biobeat

Biobeat provides a comprehensive wearable platform designed to elevate the standard of care for both short and long-term healthcare environments. Biobeat’s disposable short-term chest-monitor and long-term wrist-monitor continuously provide accurate patient readings of 13 health parameters, including cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, stroke volume, cardiac output, one lead ECG (only chest-monitor) and more. Aggregated patient health data is viewed by medical staff via Biobeat’s secure HIPAA and GDPR compliant cloud-based patient management platform, which utilizes an automated real-time early warning score (EWS) system that incorporates advanced AI-based algorithms to provide alerts on patient health status and potential deterioration. Biobeat’s wearable devices are the first devices to be FDA-Cleared for cuffless non-invasive PPG-based blood pressure monitoring and are also CE Mark certified. Founded in 2016, Biobeat is headquartered in Petah Tikva, Israel.
For more information, visit: https://www.bio-beat.com/.
Follow Biobeat on LinkedIn.

Company Contact:

Rebekah Bargraser[email protected]

Media Contact:

Maddie Stabinski[email protected]
SOURCE Biobeat

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BioStar Capital Closes Fund V at $130.3 Million, Surpassing Previous Funds

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PETOSKEY, Mich.–(BUSINESS WIRE)–BioStar Capital, a strategic venture capital firm focusing on transformative medical technologies primarily in the fields of cardiovascular disease, orthopedics, and robotics, has announced it has closed its fifth fund at $130.3 million, more than its three previous funds combined. “We have been encouraged by the level of […]

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Vaso Corporation, a Diversified Medical Technology Company Currently Trading on the OTCQX Market, to List on Nasdaq via SPAC Merger

Financial by Comments are Disabled

Business Combination with Achari Ventures Holdings Corp. I is Expected to Be Completed in First Quarter of 2024

Merger with Achari Ventures Holdings Corp. I (NASDAQ:AVHI) expected to improve capital market access for existing and prospective investors of Vaso Corporation (OTCQX:VASO).
The transaction values Vaso at a pro forma equity value of approximately $176 million at $10 per share.
Upon closing of the transaction, existing Vaso shareholders will receive consideration consisting entirely of shares of the surviving public combined company.

PLAINVIEW, NY, Dec. 7, 2023 /PRNewswire/ – Vaso Corporation (“Vaso,” or “the Company”), a diversified medical technology company currently trading on the OTCQX market, today announced its plan to uplist from the OTCQX market to the Nasdaq Stock Market via a business combination (the “Transaction”) with Achari Ventures Holdings Corp. I (“Achari”, NASDAQ:AVHI). Upon the closing of the Transaction, Vaso common stock and warrants are expected to be listed on Nasdaq Capital Market (“Nasdaq”) under the ticker symbols “VASO” and “VASOW”, respectively. Vaso’s common stock will continue to trade on the OTCQX market under the symbol “VASO” until trading on Nasdaq commences following the consummation of the proposed business combination.
Vaso is led by Chief Executive Officer Jun Ma, who will continue to lead the combined company following the proposed business combination. Achari is led by Chief Executive Officer Vikas Desai, who is also Chairman of Achari’s Board of Directors.
Company Overview
Vaso Corporation is a diversified medical technology company with several distinctive but related specialties: managed IT systems and services, including healthcare software solutions and network connectivity services; professional sales services for diagnostic imaging products; and design, manufacture and sale of proprietary medical devices.
The Company operates through three wholly owned subsidiaries:

VasoTechnology, Inc. provides network and IT services through two business units: VasoHealthcare IT Corp., a national value added reseller of Radiology Information System (“RIS”), Picture Archiving and Communication System (“PACS”), and other software solutions from various vendors as well as related services, including implementation, management and support; and NetWolves Network Services LLC, a managed network services provider with an extensive, proprietary service platform to a broad base of customers.
Vaso Diagnostics, Inc. d.b.a. VasoHealthcare, provides professional sales services and is the operating subsidiary for the exclusive sales representation of a large healthcare diagnostic imaging equipment manufacturer in certain market segments in the United States.
VasoMedical, Inc. manages and coordinates the design, manufacture and sales of proprietary medical equipment and software, as well as operates the Company’s overseas assets including China-based subsidiaries.

Transaction Overview
The Transaction values Vaso at a pro forma equity value of approximately $176 million, at $10.00 per share. The Boards of Directors of Vaso and Achari have each approved the Transaction, the consummation of which is subject to various customary closing conditions, including the filing and effectiveness of a Registration Statement on Form S-4 (as amended or supplemented, the “Registration Statement”) by Achari with the United States Securities and Exchange Commission (“SEC”), the filing and clearance by the SEC of a proxy statement by Vaso and the approval of the stockholders of both Achari and Vaso of the proposed business combination (although Vaso shareholders representing 44% of Vaso’s outstanding shares have entered into support agreements committing them to vote in favor of the Transaction). The Transaction is expected to close in the first quarter of 2024.
Additional information, including a copy of the business combination agreement, will be provided in Current Reports on Form 8-K to be filed by each of Achari and Vaso with the SEC.
Advisors
Ladenburg Thalmann & Co. Inc. is serving as financial and capital markets advisor to Vaso. Katten Muchin Rosenman LLP is acting as legal advisor to Achari and Ortoli Rosenstadt LLP is acting as legal advisor to Vaso.
About Achari Ventures Holdings Corp. I
Achari Ventures Holdings Corp. I (NASDAQ: AVHI) is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses.
Additional Information and Where to Find It
Achari intends to file with the SEC the Registration Statement, which will include a preliminary proxy statement/prospectus of Achari, which will be both the proxy statement to be distributed to holders of shares of Achari’s common stock in connection with the solicitation of proxies for the vote by Achari’s stockholders with respect to the proposed business combination and related matters as may be described in the Registration Statement, as well as the prospectus relating to the offer and sale of the securities to be issued in the business combination. Vaso intends to file with the SEC (the “Company Proxy Statement”) a preliminary proxy statement of Vaso, which will be the proxy statement to be distributed to holders of shares of Vaso’s common stock in connection with the solicitation of proxies for the vote by Vaso’s stockholders with respect to the proposed business combination and related matters as may be described in the proxy statement.
After the Registration Statement is declared effective, Achari will mail a definitive proxy statement/prospectus and other relevant documents to its stockholders. After clearance from the SEC with respect to the Company Proxy Statement, Vaso will mail a definitive proxy statement and other relevant documents to its stockholders. Achari’s and Vaso’s stockholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus to be filed by Achari, and any amendments thereto, the preliminary proxy statement to be filed by Vaso, and any amendments thereto, the definitive proxy statement/prospectus to be filed by Achari and the definitive proxy statement to be filed by Vaso, because such documentation will contain important information about Achari, Vaso and the proposed business combination. This press release is not a substitute for the Registration Statement, the Company Proxy Statement, the definitive proxy statement/prospectus to be filed by Achari, the definitive proxy statement to be filed by Vaso or any other document that Achari or Vaso will send to their respective stockholders in connection with the business combination.
INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ, WHEN AVAILABLE, THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS, COMPANY PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND THE PARTIES TO THE BUSINESS COMBINATION.
The definitive proxy statement/prospectus to be filed by Achari and the definitive proxy statement to be filed by Vaso will each be mailed to Achari and Vaso’s respective stockholders as of record dates to be established for voting on the proposed business combination and related matters. Stockholders of Achari and Vaso may obtain copies of the proxy statement/prospectus to be filed by Achari and the proxy statement to be filed by Vaso, when available, without charge, at the SEC’s website at www.sec.gov or by directing requests to each of: Vaso Corporation, 137 Commercial Street, Suite 200, Plainview, New York 11803 or Achari Ventures Holdings Corp. I, 60 Walnut Avenue, Suite 400, Clark, NJ 07066, as applicable.
INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE BUSINESS COMBINATION OR THE ACCURACY OR ADEQUACY OF THE INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
Participants in Solicitation
This press release is not a solicitation of a proxy from any investor or security holder. However, Achari and Vaso and their respective directors, officers and other members of their management and employees may be deemed to be participants in the solicitation of proxies from Achari’s and Vaso’s stockholders with respect to the proposed business combination and related matters. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of the directors and officers of Achari and Vaso in the proxy statement/prospectus to be filed by Achari relating to the proposed business combination when it is filed with the SEC and the proxy statement to be filed by Vaso relating to the proposed business combination when it is filed with the SEC. These documents may be obtained free of charge from the sources indicated above.
No Offer or Solicitation
This press release is for informational purposes only, and is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy or subscribe for any securities or a solicitation of any vote of approval, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.
Forward-Looking Statements
Certain statements in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Such forward-looking statements are often identified by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “forecasted,” “projected,” “potential,” “seem,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or otherwise indicate statements that are not of historical matters, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements and factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the effect of changes taking place across the intersection of the information technology and healthcare industries, (ii) continuation of the Company’s agreement with a major healthcare diagnostic imaging equipment manufacturer, (iii) the impact of competitive technology and products and their pricing on the Company’s technology and products, (iv) medical insurance reimbursement policies, (v) unexpected manufacturing or supplier problems, (vi) unforeseen difficulties and delays in product development programs, (vii) the actions of regulatory authorities and third-party payors in the United States and overseas, and (viii) the risk factors reported from time to time in the Company’s and Achari’s SEC reports. The forgoing factors are not exhaustive and additional factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the business combination; (2) the outcome of any legal proceedings that may be instituted against Achari or Vaso, the combined company or others following the announcement of the business combination and any definitive agreements with respect thereto; (3) the inability to complete the business combination due to the failure to obtain approval of the stockholders of Achari or Vaso or to satisfy other conditions to closing; (4) changes to the proposed structure of the business combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the business combination; (5) the ability to meet stock exchange listing standards following the consummation of the business combination; (6) the risk that the business combination disrupts current plans and operations of Vaso as a result of the announcement and consummation of the business combination; (7) the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (8) costs related to the business combination; (9) changes in applicable laws or regulations; (10) the possibility that Vaso or the combined company may be adversely affected by other economic, business, and/or competitive factors and (11) Vaso’s estimates of expenses and profitability. The foregoing list of factors is not exhaustive.
The reader should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Achari’s final prospectus dated October 14, 2021  (Registration No. 333-258476), related to its initial public offering, Achari’s and Vaso’s Annual Reports on Form 10-K filed with the SEC and other documents filed by Achari and Vaso from time to time with the SEC.
The reader is cautioned not to place undue reliance on these forward-looking statements, which only speak as of the date made, are not a guarantee of future performance and are subject to a number of uncertainties, risks, assumptions and other factors, many of which are outside the control of Achari and Vaso. Achari and Vaso expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the expectations of Achari or Vaso with respect thereto or any change in events, conditions or circumstances on which any statement is based.
SOURCE Achari Ventures Holdings Corp. I

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