PECA Labs Receives Expanded CE Mark for exGraft Family of Vascular Grafts, Allowing for Expandability Designed to Match Growth or Help Avoid Restenosis

Rhea-AI Summary

PECA Labs, a medical device company, receives an additional CE Mark for its exGraft family of vascular grafts, allowing for post-operative expansion up to 140 percent. The company also opens a new facility for polymer processing and appoints Jeffrey O’Donnell, Sr. as executive chairman.

Positive

• PECA Labs receives an additional CE Mark for exGraft vascular grafts, expanding its on-label use.
• The exGraft now includes instructions for post-operative expansion up to 140 percent with the use of oversized balloon catheters.
• PECA Labs opens a new facility for polymeric processing, moving critical manufacturing in-house.
• Jeffrey O’Donnell, Sr. is appointed as executive chairman, bringing over 25 years of board and chief executive experience in the medical device industry.

Negative

• None.

Insights

Medical Device Regulatory Expert

The recent CE Mark clearance for PECA Labs' exGraft vascular grafts represents a notable advancement in the medical device sector, particularly in the field of cardiovascular health. The clearance indicates a rigorous assessment by European regulatory bodies, affirming the device's safety and performance for expanded applications. This is pivotal for the company as it signifies a broader market access in the European Union, which is one of the largest markets for medical devices globally.

The ability of the exGraft to be post-operatively expanded up to 140 percent with oversized balloon catheters is a significant enhancement. This feature could potentially reduce the frequency of revision surgeries, especially in pediatric patients whose growth necessitates adaptability in implanted devices. For investors, this innovation could translate into a competitive edge for PECA Labs, possibly leading to increased adoption rates and market share expansion. However, it is important to monitor how this product fares against established competitors and whether it can sustainably generate revenue in the long term.

Healthcare Industry Analyst

PECA Labs' strategic move to in-house polymeric processing for its exGraft family of vascular grafts is a critical step towards operational efficiency and cost management. By centralizing manufacturing, PECA Labs could see reduced production costs, improved quality control and faster turnaround times for product development and delivery. This could result in better margins and a stronger position in the market.

Location-wise, the proximity to UPMC Children's Hospital could foster closer clinical collaborations and potentially accelerate the adoption of the exGraft in clinical settings. As the company scales up, investors should watch for how effectively PECA Labs can manage the growth in demand and whether the new facility can keep up with production without compromising quality.

Financial Analyst

The appointment of Jeffrey O'Donnell, Sr. as executive chairman is a strategic decision that could bring valuable leadership and experience to PECA Labs. O'Donnell's extensive background in the medical device industry, including successful exits and experience with taking companies public, could be instrumental in guiding PECA Labs through its next growth phase.

For stakeholders, O'Donnell's track record suggests a potential for increased investor confidence, which could be reflected in the company's stock performance. However, the true impact of his leadership will depend on the execution of the company's commercialization strategy and its ability to capitalize on the expanded CE Mark clearance. Investors should look for signs of effective leadership in the form of partnerships, product pipeline development and market expansion.

Company also elevates Jeff O’Donnell, Sr. to executive chairman and moves polymer processing in-house to new local manufacturing facility as it reaches critical inflection point

PITTSBURGH--(BUSINESS WIRE)-- PECA Labs, a medical device company reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last, has received an additional CE Mark for its exGraft family of vascular grafts, expanding its on-label use. exGraft vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased or injured vessels, and with the new clearance, exGraft now includes instructions for post-operative expansion up to 140 percent with the use of oversized balloon catheters.

The exGraft is a synthetic vascular graft built on PECA Labs’ proprietary polymer processing platform that can be permanently expanded. Post-operative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in pediatric populations or help to avoid restenosis (narrowing) in adults. Pre-operatively, the controlled dilation may help address unique anatomies. The exGraft’s capability to be balloon-expanded in the cath lab provides cardiac care teams greater flexibility in treating patients.

To help navigate the unique anatomy of each patient, exGraft also includes radiopaque markers, which help ensure accurate identification of the graft in the post-implantation period. The markers are useful during procedures in the cath lab, as well as for following patients using X-rays.

The exGraft received initial CE Mark clearance and 510(k) clearance from the U.S. Food & Drug Administration (FDA) in 2019 for use as a vascular prosthesis and has gained traction within pediatrics, being employed in more than 20 U.S. pediatric hospital centers. It has been implanted in more than 2,000 pediatric patients to date.

“This CE Mark clearance, which results in an expanded label within the exGraft family of vascular grafts, is extremely significant. Not only does it validate the potential of our controllably-expandable polymer conduit, but it also means the world to patients seeking options for a number of cardiovascular diseases and conditions,” said Doug Bernstein, CEO, PECA Labs. “Pre-operatively, exGraft expansion is designed to allow for customizable geometries to address complex anatomies, and improve outcomes of some procedures. Post-operatively, expansion via a minimally-invasive procedure is designed to provide growth potential and reduce the risk of restenosis, which is key to reducing the need for revision surgeries.”

As it ramps up commercial operations, PECA opened a new facility for polymeric processing, moving critical manufacturing in-house. With the opening of this site, PECA now has brought a significant portion of the product lifecycle in-house. Located near PECA’s headquarters in the Bloomfield neighborhood of Pittsburgh and in close proximity to University of Pittsburgh Medical Center (UPCMC) Children’s Hospital, the new site will allow PECA greater control of its manufacturing processes and the ability to scale quickly as it grows.

As the company reaches a key inflection point, PECA Labs also named Jeffrey O’Donnell, Sr. as executive chairman. Elevating Mr. O’Donnell to the role of executive chairman will help to drive the company’s strategy as it develops and commercializes cardiovascular implants based on its novel tunable polymeric material platform.

Mr. O’Donnell brings to PECA Labs more than 25 years of board and chief executive experience at emerging medical device companies. He currently serves as managing director for medtech accelerator Runway Healthcare and as managing partner at Lucius Partners. Mr. O’Donnell founded and served as CEO for Trice Medical, and before that Embrella Cardiovascular, which was acquired by Edwards Lifesciences (NASDAQ: EW). He served as president and CEO at both PhotoMedix and Cardiovascular Dynamics, taking the latter public and purchasing Radiance Medical Systems and Endologix (NASDAQ: ELGX).

In 2005, Mr. O’Donnell was named LifeSciences CEO of the Year by Price Waterhouse Coopers. In 2011, Jeff was named the Greater Philadelphia Emerging Entrepreneur of The Year by Ernst & Young. He is also currently the Chairman of the Board of Directors for AerWave Medical and Waypoint Medical. He previously served on the AdvaMed Accel Board of Directors and as an observer on the Membership, Ethics and Technology and Regulatory committees of the AdvaMed Board. Previously, Jeff served as Chairman of the Board for Strata Skin Sciences (NASDAQ: SSKN), as well as a Director on the Board at Cardiac Science and Endologix.

“This is an exciting time for PECA Labs, with its important work about to be realized on a much larger scale,” said Mr. O’Donnell. “The company shows great promise, with innovative technologies that I believe will be a game-changer in the cardiovascular space, providing a great benefit to patients, surgeons and interventionalists alike.”

About PECA Labs

PECA Labs is reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices that are designed to fit, grow and last to help patients avoid repeat surgeries and reduce morbidity and mortality. PECA’s proprietary technologies, a controllably-expandable graft and low-thrombosis polymeric membrane, consist of a proprietary tunable polymer material platform that represents a new approach in engineering synthetic materials for greater durability and customization than currently available cardiovascular implants. The company’s grafts and conduits are designed to lead to a longer lifespan compared to currently available products, due to resistance to thrombosis, calcification and immune response, and by providing growth potential, customization, and noninvasive visualization. For more information visit www.pecalabs.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240319800090/en/

Media Contact:

Joe Duraes

Pazanga Health Communications

jduraes@pazangahealth.com

(917) 687-6419

Source: PECA Labs

FAQ

What is the significance of the additional CE Mark received by PECA Labs for its exGraft family of vascular grafts?

The CE Mark allows for post-operative expansion up to 140 percent with the use of oversized balloon catheters, expanding the on-label use of the exGraft vascular grafts.

Where is the new facility for polymer processing opened by PECA Labs located?

The new facility for polymer processing is located near PECA's headquarters in the Bloomfield neighborhood of Pittsburgh, in close proximity to University of Pittsburgh Medical Center (UPCMC) Children’s Hospital.

Who has been appointed as executive chairman of PECA Labs?

Jeffrey O’Donnell, Sr. has been appointed as executive chairman of PECA Labs, bringing over 25 years of board and chief executive experience in the medical device industry.