R3 Vascular Submits IPO Prospectus Following $87M Series B Financing for Its Ultra-Thin Bioresorbable Magnitude BTK Scaffold

May 14, 2024 00:05 CST Updated 00:05

R3 Vascular

Vascular Stent Developer

On May 9, 2024, bioresorbable scaffold manufacturerR3 Vascular Announced the completion of an $87 million (approximately 626 million RMB)Series B Financing, and appointed Christopher Owens as President and Chief Executive Officer.

R3 Vascular Plans to use the funds to support itsMagnitude StentThe ELITE FDA Investigational Device Exemption (IDE) trial, focusing on Magnitude therapyBelow-the-Knee (BTK) PADThe effect.

# Magnitude Bioabsorbable Stent

ByUltra-high molecular weight polylactic acid polymerThis polymer, combined with stent design and proprietary processing technology, makes the stent thinner, stronger, and more flexible.

The stent is specifically designed,ItsThe pillar is only98μmThinner than Esprit BTK,Can ensure gradual absorption into the tissue, leaving a more naturally functioning blood vessel.

Product Advantages:

The degradation time is predictable, and the ratio of amorphous and crystalline domains of ultra-high molecular weight polylactic acid polymer was incorporated during the design process.
High Radial Strength and Circumferential Support；Balance of Strength and Ductility;
The polymer undergoes degradation during the process.With significant structural stability;Ultra-thin design.

Clinical Data:

In November 2023, R3 Vascular announced the 6-month follow-up results of the RESOLV I First-in-Human trial.

ResearchPrimary Safety Endpoint: 6 months free from MALE, including amputation above the ankle of the affected limb or major reintervention, and perioperative mortality (30-day mortality).

Primary Efficacy Endpoint: 6-month freedom from TLR and contrast一期通畅率;

Secondary Endpoint:Including technical success, surgical success, imaging results, and clinical outcomes.

A total of 30 patients were enrolled (5 with Rutherford grade 3, 3 with Rutherford grade 4, and 22 with Rutherford grade 5), with an immediate success rate of 100%.

Rutherford Grade 5 Lesion Immediate Lumen Gain2.2±0.4 mm, Immediate residual lumen stenosis after surgery was14.8％±6.8％, Residual lumen stenosis at 6-month postoperative follow-up＜30％。

In terms of the primary endpoint,The incidence rate of being free from MALE at 6 months is100％; Free from restenosis or no-reflow, only Rutherford grade 5 group90％, the rest are all 100%.

# Financing Information

Deerfield Management Affiliate Leads R3 Vascular InvestmentVascular The B-round financing. Existing shareholders, including 415 Capital and strategic investors, also participated.

During the financing process, David Neustaedter (upper left) and Dr. Michael Hurley (upper right) from Deerfield joined the board of directors.

R3 Vascular Plans to Use the Funds to Support Its Magnitude Stent ELITE FDA Investigational Device Exemption (IDE) Trial, Focusing on the Efficacy of Magnitude in Treating Below-the-Knee (BTK) PAD.

Besides, the funds are also used forAdditional R&D, Global Regulation, Production Scale Expansion, and Initial CommercializationWork.

# New CEO

Christopher Owens, with over thirty years of experience in medical devices, served as the President and Chief Executive Officer of Gynesonics, a manufacturer of women's health medical devices;Formerly served as President and CEO of IDEV Technologies, a company that developed the Supera Veritas stent system for PAD. Abbott acquired IDEV in 2013.

"I am delighted to join R3 Vascular and work closely with the other members to build on this progress. R3 Vascular’s novel bioresorbable scaffold, which incorporates world-class polymers and stent design, has the potential to further improve treatment outcomes for patients with PAD.”

# About R3R3 Vascular

R3 Vascular, Inc., an innovative medical device company, is dedicated to developing best-in-class bioresorbable scaffolds that rival metal drug-eluting stents. Its unique polymer and proprietary technology are used to create scaffolds that balance strength and flexibility for the treatment of peripheral artery disease (PAD).

Magnitude has a strut thickness of 98 microns across all available diameter ranges, making it the thinnest absorbable stent tested in this clinical setting.

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Editor-in-Chief | Zhao Qing Reviewed by | Yi He