Frontier Bio creates engineered tissues to replace animal testing and save lives. Pulse 2.0 interviewed Frontier Bio’s Head of Vascular Tissue Engineering Sam Pashneh-Tala to learn more.
Sam Pashneh-Tala’s Background
Pashneh-Tala has a background in tissue engineering in academia. And Pashneh-Tala said:
“I have undergraduate degrees in both biology and mechanical engineering and then completed my PhD at the University of Sheffield with a focus on tissue engineering. I then worked as a research fellow for five years, developing various technologies relating to tissue-engineered blood vessels and biomaterials in collaboration with clinicians and the industry. Before joining Frontier Bio, I ran my own boutique consultancy specializing in tissue-engineered medical devices.”
“As the Head of Vascular Tissue Engineering, I direct all vascular-related projects and manage a small research team. Frontier Bio has a mixture of internal R&D projects focused on product development, along with externally funded contract research too. Being a small company, I wear many hats and also have significant involvement in grant writing, business development, and marketing.”
Core Products
What are the company’s core products and features? Pashneh-Tala explained:
“Frontier Bio is focused on delivering tissue engineering technologies to provide alternatives to animal testing and to provide tissues/organs for people requiring transplants. Our core areas of interest are lung, neuronal, and vascular tissues. We have a number of products in development, including tissue-engineered blood vessels as models for testing vascular medical devices and lung microtissues and vascularized neurospheres for in vitro model applications in toxicology and drug development. We also provide contract research services, enabling us to support client innovation by leveraging our team’s expertise in the multidisciplinary field of tissue engineering.”
Polymer scaffold used to produce tissue-engineered blood vessels in the shape of an aneurysm. Left: Macroscopic, Right: Microscopic.
Favorite Memory
What has been your favorite memory working for the company so far? Pashneh-Talareflected:
“I have really enjoyed developing collaborations with industry and clinicians. We have recently begun a collaboration with a leading vascular surgeon. This will be key in advancing our tissue-engineered blood vessel technology towards the clinic.”
“I also enjoyed exhibiting some of our work at the recent American College of Surgeons Clinical Congress in Boston.”
Evolution Of Frontier Bio’s Technology
How has the company’s technology evolved since launching? Pashneh-Tala noted:
“The focus of the company was initially on developing bioprinter technology. We developed the Flux 1 bioprinter and shipped a number of units. However, we decided to pivot to developing the tissue-engineered products ourselves, leveraging our own bioprinting technology and know-how.”
Bioreactor used to grow tissue-engineered blood vessels.
Significant Milestones
What have been some of the company’s most significant milestones? Pashneh-Tala cited:
“We have filed several patent applications related to tissue-engineered blood vessel technology and vascularized neurospheres.”
“We also received an SBIR phase 1 grant from the National Science Foundation to develop our tissue-engineered blood vessel technology. In this project, we worked with Mayo Clinic to develop a tissue-engineered aneurysm model for use in medical device testing. The work was completed in 2022, and we have subsequently submitted our phase 2 proposal to continue the development of the technology.”
“This year, we also achieved a significant sales milestone, exceeding $4 million in sales generated by the business. This came through contract research work with customers, including major medical device companies and charitable trusts.”
Customer Success Stories
After asking Pashneh-Tala about customer success stories, he highlighted:
“We have fostered a healthy relationship with the Wellcome LEAP initiative through their SAVE program. SAVE aims to increase global access to surgery and includes a broad cohort of global expertise, including clinicians, engineers, scientists, academics and policy makers. As part of the SAVE program, Frontier Bio is providing contract research services developing tissue mimics as advanced models for training in laparoscopic surgery.”
“These are the most advanced synthetic tissue models ever created with mechanical and handling properties similar to real tissue. Our tissue mimics even respond to electrosurgery enabling surgeons to develop their skills in tissue cauterization, a unique feature. We have developed a prototype gallbladder model and recently displayed this at the American College of Surgeons Clinical Congress in Boston. The prototype was met with high praise, including the comments ‘it feels like a real gallbladder’ and ‘this is the best model I’ve ever used.’”
“We have also recently received funding for a second project developing a model of the abdominal wall to help in teaching trocar insertion for laparoscopic surgery.”
“We hope to continue to work with the Wellcome LEAP SAVE program as it operates through to 2026.”
Funding/Revenue
After asking Pashneh-Talaabout funding and revenue information, he revealed:
“Frontier Bio has raised $3 million in investment from VC firms and angel investors. We have subsequently generated $4.7M in sales through contracted services and grants. We have seen a significant ramp-up in sales from about $500k in 2021. We project to reach $6 million in 2024.”
“We are currently raising through a pre-series A round with the intention to raise our series A in late 2024.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Pashneh-Talaassessed:
“As mentioned above, we have verticals related to neuronal and lung tissue, and blood vessels. I will concentrate on discussing the blood vessels here.”
“Our initial target market is in vitro testing. We will produce tissue-engineered blood vessels to replace animal models in medical device testing. Our lab-grown vessels will be less expensive and also represent a more ethical choice for medical device developers. The TAM size here is estimated at $1.1B globally. This is a growing market due to the increasing need for treatments for cardiovascular disease, which remains the number 1 cause of death worldwide.”
“We are currently pursuing having our tissue-engineered blood vessels qualified as medical device development tools (MDDT) by the FDA. This qualification will enable device developers to use our model instead of the established animal models for regulatory clearance. The FDA has recently developed the MDDT program in order to encourage the development of alternatives to animal models. This aligns with the recent FDA Modernization Act 2.0, which includes a focus on reducing the use of animals in drug and medical device development.”
“Going beyond the in vitro market, Frontier Bio also plans to deliver tissue-engineered blood vessels into the clinic, providing new solutions for vascular grafting. This represents a market estimated at about $14 billion globally.”
Differentiation From The Competition
What differentiates the company from its competition? Pashneh-Talaaffirmed:
“We believe that we are different from other tissue engineering companies because of our focus on in vitro applications prior to the clinic. Commonly, tissue engineering technology is aimed at generating clinical solutions to produce replacement tissues. This technology takes a long time to mature and pass through the appropriate regulatory steps and clinical trials to be approved for commercial release. This timeline places significant challenges on companies developing the technology in terms of revenue generation.”
“Our focus on delivering in vitro technologies initially will allow us to generate significant revenue in the early/mid-term, de-risking the development of our clinical solutions.”
Future Company Goals
What are some of the company’s future company goals? Pashneh-Talaconcluded:
“We aim to achieve MDDT qualification for our tissue-engineered blood vessels in 2025 and to begin to generate revenue from these.”
“We aim to have our first tissue-engineered blood vessel implanted in a human in 2027.”
