Nurami Medical announces positive results from its brain surgery clinical trial
Nurami Medical, which is developing a biodegradable surgical patch for Dura repair in neurosurgeries, has achieved its key endpoint in its clinical trial. The next clinical milestone is receiving FDA approval.
Nurami Medical Announces Positive Results from its Brain Surgery Clinical Trial. Almeda Ventures, a HealthTech focused public R&D partnership has announced that Nurami Medical, which is developing a biodegradable surgical patch for Dura repair in neurosurgeries, has achieved its key endpoint in its clinical trial. The next clinical milestone is receiving FDA approval.
Almeda Ventures, a HealthTech focused public R&D partnership which invests in medical device digital health startups, has announced today (Wednesday) positive results of Nurami Medical’s trial. Almeda Ventures holds a 13% of Nurami Medical, which was established in 2014 by Nora Nseir and Dr. Amir Bahar. Nurami, which is jointly managed by Nora Nseir and Hannoch Marksheid develops innovative technologies for soft tissue repair and expediated healing after surgical procedures.
The company’s first product, ArtiFascia, is a synthetic, biodegradable surgical patch for Dural repair in neurosurgeries. Eighty-five patients have completed the follow-up period of ArtiFascia’s pivotal clinical trial (a large-scale trial to prove efficacy of a medical device). Of these patients, fifty-eight were implanted with Nurami’s product and twenty-seven were the control group, and were implanted with alternative, commercially available products for Dura repair in neurosurgical procedures.
The trial’s results proved that Nurami’s product successfully achieved all endpoints. The primary target endpoint was to achieve no CSF leaks from the brain or spine. Nurami’s product had no leaks whatsoever, while the control group, which used regulatory approved alternative showed an aggregate 3.7% leakage rate.
Secondary endpoints included: Subgaleal accumulation – Nurami achieved this endpoint with only 1.7% of Nurami treated patients demonstrating this accumulation, compared to 7.4% in the control group.
Additional secondary endpoints included grading the product’s usability, specifically, its strength, ease of use, ease of cutting the graft, and suturability. In each of these Nurami’s product scored a statistically significant higher grade than the products used in the control group.
Almeda Ventures has notified the TASE that “the positive results bring Nurami one step closer to receiving FDA approval in the US”.
Nurami’s potential market for its tissue repair technology is projected to reach $25B annually by 2025. Almeda Ventures has invested US$2M in Nurami’s last round in 2020. Nurami has raised a total of US$11 million, from Arkin group and additional investors and is projected to raise an additional round to fund continued product R&D and marketing.
Translated from Hebrew from a TheMarker article from September 21,2022 by Yosef Harash