Peripheral/Endo

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

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.

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

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

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

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.

Continue Reading

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.

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

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 […]

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

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

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

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

Favorable Oncocyte VitaGraft Kidney Study Results Published in the New England Journal of Medicine

Late-breaking presentation of data at American Transplant Congress on Monday, June 3Data show potential to monitor for therapeutic efficacy and recurrencePotential repeat testing opportunities with claims expansion IRVINE, Calif., May 30, 2024 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced that favorable data regarding its lead product VitaGraft™ Kidney was published in the New England Journal of Medicine. Oncocyte’s Drs. Ekke Schuetz and Julia Beck, inventors of the technology, are among the authors of the study. VitaGraft Kidney was used to monitor graft injury in a phase 2 double-blind, placebo-controlled study (NCT05021484) of the investigational drug felzartamab, a fully human CD38 monoclonal antibody, for antibody-mediated rejection (AMR), a leading cause of kidney allograft failure. VitaGraft Kidney measures the amount of DNA in transplant patients’ blood that comes from the donor organ, a key biomarker for assessing graft health. This process is commonly referred to as donor-derived cell-free DNA (dd-cfDNA) testing and is widely used in clinical practice today. In this study, Oncocyte’s proprietary diagnostic test using droplet-digital PCR was able to identify responders and non-responders to felzartamab, showing, “a decrease in dd-cfDNA fractions at week 12 (0.33% [0.25−0.40] versus 0.95% [0.37−1.63]; mean difference: −0.75%; 95% CI: −1.41, −0.09) and week 24 (0.31% [0.21−0.49] versus 0.82% [0.34−2.90]).” The study points to new clinical utilities for VitaGraft Kidney beyond the Company’s currently approved and reimbursed indication of for cause testing. Both therapeutic efficacy and recurrence monitoring are potential new use cases for dd-cfDNA testing. Both utilities would be expected to require multiple tests during the active management phase, when a drug is being given, and long-term to help doctors watch for AMR recurrence. “The results of the phase 2 trial suggested that monitoring of dd-cfDNA could be useful to accurately detect responsiveness to felzartamab therapy, also uncovering disease recurrence after stopping treatment,” said Dr. Georg Böemig, Medical University of Vienna, senior author of the publication. “Therefore, the assay could have high potential as a tool to individually guide dosing intervals and duration of anti-rejection therapy.” Up to 20.2% of kidney transplant patients will develop AMR within 10 years of transplant and up to 70% of those patients will progress to graft failure.1 Currently, there are no FDA approved drugs that have indications for the management of AMR. Results of the phase 2 trial suggest that the combination of felzartamab drug therapy and VitaGraft Kidney testing may have significant potential to address this key unmet need in transplant management by enabling detection, management, and monitoring of AMR. “We congratulate the research teams on this groundbreaking study and its potential to lead to a treatment option for kidney transplant patients suffering from AMR around the world,” said Josh Riggs, Oncocyte CEO. “We are grateful for the support from our research partners and their inclusion of our test in this study. It is exciting to see a new opportunity for Oncocyte’s technology to serve the clinical market and patients in need. This study, combined with earlier results showing that our test can detect AMR up to 10 months earlier than protocol, points to new opportunities to improve care and outcomes for these high-risk patients. In the future, we expect that VitaGraft will be there to support physicians looking to detect AMR as early as possible and then effectively manage this disease.” “Our recent partnership with Bio-Rad, gives us the scale we need to support the global transplant research community with easy-to-use dd-cfDNA monitoring tools,” continued Mr. Riggs. “Use cases like this will help drive adoption of our combined technology around the world.” The results of this publication will be discussed as a Late Breaking Abstract at the 2024 American Transplant Congress on June 3rd 2024 at 9:15 ET by Dr. Katharina Mayer from the Medical University of Vienna. Oncocyte will be exhibiting at the conference at Booth #430. Oncocyte will be hosting a conference call to discuss the results of the clinical trial with study authors, Dr. Klemens Budde, Head of Transplantation at Charite, and Dr. Ekke Schuetz, Chief Science Officer at Oncocyte. Dr. Schuetz developed the dd-cfDNA technology as CEO and CSO of Oncocyte subsidiary Chronix Biomedical alongside Dr. Julia Beck. The clinical presentation will be followed by an operational update and Q&A focused on the commercial launches of VitaGraft Kidney and GraftAssure by Josh Riggs. Investors may submit questions for the Q&A by emailing them to the contact information listed below. The date and time of the call will be announced in due course. 1 Mujtahedi, S.S., Yigitbilek, F., Ozdogan, E. et al. Antibody-Mediated Rejection: the Role of Plasma Cells and Memory B Cells. Curr Transpl Rep 8, 272–280 (2021). https://doi.org/10.1007/s40472-021-00342-1 About Oncocyte Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test. GraftAssure™ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/. For more information about our products, please visit the following web pages: VitaGraft Kidney™ – https://oncocyte.com/vitagraft-kidney/VitaGraft Liver™ – https://oncocyte.com/vitagraft-liver/GraftAssure™ – https://oncocyte.com/graftassure/DetermaIO™ – https://oncocyte.com/determa-io/DetermaCNI™ – https://oncocyte.com/determa-cni/ VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation. About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with late AMR affecting approximately 23,000 patients total in the U.S. There is no effective treatment for AMR and patient options are highly limited. Donor-specific antibody (DSA) production by plasma cells, and tissue infiltration of Natural Killer (NK) cells presumed to be involved in DSA-dependent microvascular inflammation, are both linked to AMR. Observations that both plasma cells and NK cells express high levels of CD38 have motivated the approach of targeting CD38 to deplete these cell populations to address AMR. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority. Forward-Looking Statements Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, the future of VitaGraft Kidney, the anticipation that Oncocyte and Bio-Rad’s combined technology will be adopted around the world, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CONTACT: Jeff RamsonPCG Advisory(646) 863-6893jramson@pcgadvisory.com

InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024  

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis at this year’s Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany. Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have such a significant presence at this year’s LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study. The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization market with the best implant in CGuard Prime.” Dr. Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, “We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid disease, including 25% who were symptomatic. These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease.” Presentation details: Title:One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the CGuard™ Carotid Stent SystemPresenter:Dr. D. Christopher Metzger, System Vascular Chief, OhioHealthDate/time:Tuesday, May 28th at 2:53 pm CEST (8:53am EDT)   Presentation Highlights: From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.Stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a primary endpoint event rate of 1.95%, from procedure through 1-year follow-up.The presentation is available on our website at: Clinical Presentations – InspireMD About LINCLINC, the Leipzig Interventional Course, is strongly committed to contributing to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions. For more information, please visit: https://www.leipzig-interventional-course.com/ About C-GUARDIANSThe C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure, or ipsilateral stroke from 31‐365-day follow‐up, based on the Clinical Events Committee (CEC) independent adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is