Peripheral/Endo

New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation

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Temporary vessel occlusion a growing practice for trauma patients.
SALT LAKE CITY, June 13, 2024 /PRNewswire/ — Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.
REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.
“Landmark was easy to use and easy to deliver with a smooth insertion,” said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. “REBOA can be an important tool to aid in patient resuscitation.” It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2
“We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage,” said Ryan Murri, Emergency Scientific’s Chief Executive Officer. “With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options.”
The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.

Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023). 
Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.

SOURCE Emergency Scientific

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel

EINDHOVEN, The Netherlands, June 13, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.
aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for hemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG). The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.
Xeltis’ groundbreaking implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients’ own living healthy tissue. Xeltis’ novel technology has already treated over 100 patients across different clinical trials.   
Eliane Schutte, Chief Executive Officer, Xeltis commented: “We have already shown outstanding 12-month data from our first-in-human study in Europe and are looking forward to starting this pivotal trial in the US. We are very proud of the potential for aXess to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to hemodialysis patients worldwide.”
Paulo Neves, Chief Medical Officer, Xeltis said: “Our focus is on improving the outcomes for patients on dialysis. aXess offers this potential through its avoidance of the reinterventions and complications associated with other vascular access solutions. This pivotal study is important in assessing and demonstrating this and marks a significant milestone in our clinical strategy in the US.”
The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.
About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. 
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.
About aXessaXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.
A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. A pivotal trial of aXess is currently enrolling up to 110 patients in nine EU countries.
Go to axesspivotal.com for more details.
SOURCE Xeltis

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Surmodics Awarded Thrombectomy Products Agreement with Premier, Inc.

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EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has been awarded a group purchasing agreement for thrombectomy products with Premier, Inc. Effective June 1, 2024, the new agreement allows Premier members, at their discretion, to take advantage […]

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BioMarin Presents New Phase 3, Four-Year Data Underscoring Long-Term Safety and Efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) at International Society on Thrombosis and Haemostasis 2024 Congress

Peripheral/Endo by Comments are Disabled

Data from Longest and Largest Hemophilia Gene Therapy Study Show Durable and Sustained Bleed Control and Factor VIII Expression Maintained Four Years Post-ROCTAVIAN Infusion
Additional Data Show Meaningful Impact of ROCTAVIAN on Health-Related Quality of Life (HRQoL) 
SAN RAFAEL, Calif., June 7, 2024 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that new data supporting the long-term safety and efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) will be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand, June 22-26, 2024.
“We are pleased to share data at ISTH demonstrating that ROCTAVIAN continues to offer durable and sustained bleed control and endogenous factor VIII expression four years after the infusion, representing the longest and largest Phase 3 follow-up results of a gene therapy in hemophilia,” said Hank Fuchs, M.D., president of Worldwide Research and Development at BioMarin. “Importantly, these Phase 3 data also indicate a plateauing of factor VIII levels after year three with the majority of patients remaining off prophylaxis, which shows ROCTAVIAN can offer long-term bleed protection for adults with severe hemophilia A and may provide relief from the burden of chronic infusions and injections.”  
Four-Year Data from Largest Phase 3 Hemophilia Gene Therapy Study Demonstrate Long-Term Safety and Efficacy of ROCTAVIANThe Phase 3 GENEr8-1 trial demonstrated that durable bleed control and sustained factor VIII (FVIII) expression were maintained four years after treatment with ROCTAVIAN, with FVIII activity near stable compared with results reported previously and no new safety signals observed. Of the 134 patients who received ROCTAVIAN in the study, the rollover population of 112 patients had baseline annualized bleeding rate (ABR) data prospectively collected during a period of at least six months while on routine FVIII prophylaxis prior to receiving ROCTAVIAN, and two of the 112 patients discontinued the study prior to year four. During year four, 73.6% of the remaining participants (81/110) had zero treated bleeds. Over the entire study period to the time of the data cut, 24 of the 134 total participants resumed prophylaxis with either FVIII or emicizumab without any complications. Mean FVIII activity at the end of year four (n=130) was 27.1 and 16.1 IU/dL as assessed by one-stage assay (OSA) and chromogenic assay (CSA), respectively. These levels are near stable from the previously reported three-year data. Over four years, the mean ABR for treated bleeds for the rollover population was 0.8 bleeds/year, and the mean ABR for all bleeds was 1.3 bleeds/year.
Table 1. Rates of bleeding and FVIII use over four years post-ROCTAVIAN treatment in the rollover population (N=112)

Baseline
Year four
All post-prophylaxis cessation (week 5 to data cutoff)

(n=112)
(n=110)
(n=112)

ABR (treated), bleeds/year

Mean ± standard deviation (SD)
4.8 ± 6.5
0.9 ± 2.3
0.8 ± 2.0

Median (Q1, Q3)
2.8 (0.0, 7.6)
0.0 (0.0, 1.0)
0.0 (0.0, 0.5)

  Annualized FVIII infusion rate, number/year

Mean ± SD
135.9 ± 52.0
10.6 ± 29.5
6.1 ± 15.6

Median (Q1, Q3)
128.6 (104.1, 159.9)
0.0 (0.0, 3.0)
0.6 (0.0, 3.0)

  ABR (all), bleeds/year

Mean ± SD
5.4 ± 6.9
1.2 ± 2.5
1.3 ± 2.2

Median (Q1, Q3)
3.3 (0.0, 7.9)
0.0 (0.0, 1.0)
0.5 (0.0, 1.3)

  Participants with 0 bleeds (treated), n (%)
36 (32.1)
81 (73.6)
61 (54.5)

  Participants with 0 bleeds (all), n (%)
34 (30.4)
68 (61.8)
29 (25.9)

Results Suggest Positive Impact of ROCTAVIAN on Health-Related Quality of LifeIn an additional analysis from the Phase 3 GENEr8-1 study, ROCTAVIAN provided important improvements in health-related quality of life (HRQoL) over four years in people with severe hemophilia A, even for those with FVIII levels below 5%. These improvements were measured using the Haemo-QOL-A assessment, a questionnaire designed to measure HRQoL in people with hemophilia A and B. Four years after treatment, the average Haemo-QOL-A Total Score increased by 6.2 points from baseline, with improvements observed in Physical Functioning (4.8 points), Role Functioning (5.9 points), and Consequences of Bleeding (9.2 points). Based on FVIII activity at year four, average Haemo-QOL-A Total Score increased by 6.3, 5.8, and 6.9 points for participants with FVIII activity in ranges ≥40%, ≥5% to ULN. Patients also experienced adverse reactions from corticosteroid use.
Isotretinoin, Efavirenz, and HIV Positive Patients: Isotretinoin is not recommended in patients who are benefiting from ROCTAVIAN. Efavirenz is not recommended in patients treated with ROCTAVIAN. Clinical studies of ROCTAVIAN did not include sufficient numbers of patients with HIV to determine whether the efficacy and safety differs compared to patients without HIV infection.
Females and Males of Reproductive Potential: ROCTAVIAN is not intended for administration in women. There are no data on the use of ROCTAVIAN in pregnant women or regarding lactation. For 6 months after administration of ROCTAVIAN, men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception, and men must not donate semen.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to BioMarin at 1-866-906-6100.
Please see the ROCTAVIAN full Prescribing Information for additional Important Safety Information.
About BioMarin
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin’s unparalleled research and development capabilities have resulted in eight transformational commercial therapies for patients with rare genetic disorders. The company’s distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. For additional information, please visit www.biomarin.com.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: data to be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis, including the oral and poster presentations; the development of BioMarin’s ROCTAVIAN program generally; the safety profile, efficacy and potential positive impact of ROCTAVIAN for adults with severe hemophilia A; and the potential benefits of ROCTAVIAN for adults with severe hemophilia A, including offering long-term bleed protection, providing relief from the burden of chronic infusions and injections, helping treated patients move more freely and reducing the burden of caring for bleeding episodes. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of ROCTAVIAN; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the Food and Drug Administration, the European Commission and other regulatory authorities; BioMarin’s success in the commercialization of ROCTAVIAN, including achieving adequate market share and reimbursement levels; whether ROCTAVIAN will have the impacts and benefits as anticipated; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin® and ROCTAVIAN® are registered trademarks of BioMarin Pharmaceutical Inc.

Contacts:

Investors                               
Media

Traci McCarty                   
Andrew Villani

BioMarin Pharmaceutical Inc.        
BioMarin Pharmaceutical Inc.

(415) 455-7558                  
(628) 269-7393

SOURCE BioMarin Pharmaceutical Inc.

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AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study

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June 06, 2024 07:58 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its pivotal […]

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CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath

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BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysis can be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. The company estimates that up to 100,000 HD-CVC placements occur each year, and pass-through status ensures that providers are reimbursed separately for administration of DefenCath in this setting of care. Given that approximately 50% of catheter-related bloodstream infections, or CRBSIs, can occur within the first 90 days that a catheter is inserted, it is critical to protect the line beginning at the time of placement. DefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath. LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. DefenCath is contraindicated and has warnings and precautions in patients with: Known heparin-induced thrombocytopenia (HIT).Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.  If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures. To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see the full Prescribing Information. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576

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First Commercial Use of Baylis Medical Technologies’ PowerWire® Pro for In-Stent Restenosis

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MISSISSAUGA, ON, June 5, 2024 /PRNewswire/ – Baylis Medical Technologies today announced the completion of its first clinical use of the PowerWire® Pro Radiofrequency (RF) Guidewire to safely cross a chronically occluded peripheral stent.

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Photograph of Dr. Iafrati and his team holding up a PowerWire® Pro box after their successful case. (CNW Group/Baylis Medical Technologies Inc.)

The procedure was performed in April 2024, by Mark Iafrati, MD, Professor of Vascular Surgery in Nashville, TN. The patient was suffering from a chronically occluded stent that extended from the inferior vena cava (IVC) down to the left common iliac vein. Previous attempts to cross the occlusion with mechanical tools were unsuccessful, likely owing to the dense fibrotic nature of the occlusion. The patient was brought back and Dr. Iafrati performed the procedure with the PowerWire Pro RF Guidewire, which utilizes RF energy to vaporize a channel through occlusions, allowing for successful crossing and subsequent revascularization of the iliocaval stent. 

“This marks a significant advancement in the treatment of patients with in-stent restenosis”, commented Dr. Iafrati. “I was able to easily cross the occluded stents with the PowerWire Pro RF Guidewire when my standard tools had failed.”
This spring, the FDA cleared Baylis Medical Technologies’ PowerWire Pro RF Guidewire, a device designed to cross occluded peripheral vessels, including those with stents, using radiofrequency technology.Frank Baylis, Executive Chairman of Baylis Medical Technologies, expressed enthusiasm about the PowerWire® Pro RF Guidewire’s potential impact, stating, “This innovation aims to simplify the often challenging and time-consuming process of crossing chronic occlusions in revascularization procedures, ensuring uninterrupted patient treatment.”
About Baylis Medical Technologies Inc.
Baylis Medical Technologies seeks to improve the lives of patients through the conception and commercialization of state-of-the-art medical devices. The company proudly carries forward Gloria Baylis’ legacy to enhance access to care through its divisions of Endovascular and Design and Manufacturing Services. Baylis Medical Technologies’ clinical solutions are utilized by healthcare professionals worldwide to improve patient outcomes for individuals with cardiovascular and other medical conditions. Learn more about our innovative products and ongoing mission at www.baylismedtech.com.For any inquiries, please contact [email protected] or call 1-888-505-4885

PRM-00910 J-1 V-1 © Baylis Medical Technologies Inc., 2024. PowerWire is a trademark and/or registered trademark of Baylis Medical Technologies Inc. in the United States and other countries. Baylis Medical Technologies Inc. reserves the right to change specifications or to incorporate design changes without notice and without incurring any obligation relating to equipment previously manufactured or delivered. Patents Pending and/or issued. CAUTION: Federal Law (USA) restricts the sale of these devices to or by the order of a physician. Before use, consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.

SOURCE Baylis Medical Technologies Inc.

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Shape Memory Medical Announces First Patient Treated in the AAA-SHAPE Randomized Controlled Pivotal Trial

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SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm […]

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Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial

Peripheral/Endo Regulatory by Comments are Disabled

BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration’s (“FDA”) approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial. In parallel to commencing the pivotal human clinical trial, the Company is completing its biocompatibility tests as required by its IDE application. “The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” commented Harel Gadot, CEO, President and Chairman. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe”. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty+972-(0)52-3044404IR@microbotmedical.com

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Elastin Biosciences Announces Positive Preclinical In Vivo Data Demonstrating Elastin Preservation and Restoration in Models of Abdominal Aortic Aneurysm and Williams Syndrome

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Mice treated with Elastin Restoration Platform demonstrated five-fold increase in elastin expression, improved metabolic profile, reduced pro-inflammatory markers, and significant improvement in aorta arterial tensile strength
LONDON, June 3, 2024 /PRNewswire/ — Elastin Biosciences, an emerging biotechnology company focused on developing small molecule therapies to address diseases and conditions linked to elastin deficiency, today announced promising preclinical data from its in vivo mouse model studies.. The studies highlight the efficacy of the company’s Elastin Restoration Platform in enhancing elastin expression and improving arterial tensile strength, offering a potential breakthrough for conditions such as abdominal aortic aneurysm and Williams syndrome.
The Elastin Restoration Platform, which utilizes a combination of proprietary molecules, resulted in a five-fold increase in elastin expression and significantly improved arterial tensile strength of the aorta in mouse models. The therapy improved the overall metabolic profile and reduced pro-inflammatory markers without adverse effects, indicating a favorable safety profile and potential for broad therapeutic application. Additionally, treated mice showed a marked increase in elastin deposition biomarkers.
These results align with data from a prior proof-of-concept in vivo mouse study in which mice treated with the Elastin Restoration Platform showed significant improvements compared to untreated mice, such as enhanced coat color (from spotted gray to all black), better coat quality with less damage, and improved behavioral markers in tests assessing mobility and anxiety.
“These positive preclinical findings highlight the potential of our Elastin Restoration Platform to address critical conditions associated with elastin deficiency,” stated Sherif Idriss, Ph.D., CEO of Elastin Biosciences. “Our approach has demonstrated both therapeutic efficacy and potential for tissue recovery and regeneration, bringing us closer to developing effective treatments for numerous age-related diseases including those associated with the skin, lungs, and blood vessels. Notably, our treatment produced initial indications of efficacy in Williams syndrome, recovering the expression of five genes that are partially deleted in the aorta.”
Dr. Idriss continued, “Based on these data, our next step is to have our molecule combination advance to IND-enabling studies later this year, with the aim to initiate Phase 1 clinical trials by January 2026. Additionally, the Company is exploring other indications and therapies to maximize the benefits of our Elastin Restoration Platform.”
About Elastin:Elastin is a crucial protein in the human body, providing elasticity and resilience to tissues such as skin, lungs, and blood vessels. Its degradation due to aging leads to reduced tissue function and is associated with various age-related diseases. By mitigating elastin loss, therapies can potentially improve patients’ quality of life and longevity.
About Elastin Biosciences:Elastin Biosciences is an emerging biotechnology company developing small molecule therapeutics to address diseases linked to elastin deficiency. The Company’s Elastin Restoration Platform leverages a combination of proprietary molecules designed to fortify the structural integrity of crucial tissues, including those in the cardiovascular and epidermal systems.  Elastin’s lead development program has demonstrated an ability to increase elastin expression and arterial tensile strength in models of abdominal aortic aneurism and Williams syndrome, a rare a multisystem disorder characterized by elastin arteriopathy.  Elastin Biosciences emerged from Longaevus Technologies and is based in London.  For more information, please visit www.elastin-biosciences.com
Investor and Media Contact:Tiberend Strategic Advisors, Inc.
David Irish[email protected]231-632-0002
Eric Reiss[email protected]
SOURCE Elastin Biosciences

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