In our Spinout Stories blog series, PCI features a Penn-affiliated company that leveraged programs like PCI Ventures and I-Corps on their path to commercialization. Paradigm Surgical is one such startup success story. What started as an idea in Dr. John Fischer’s lab to improve abdominal surgery for hernias, is now a five year old medical device startup well on their way through Phase II device testing.
A Problem In Need of a Solution
Each year, approximately 350,000 people experience hernia requiring surgery. The most successful treatment, onlay mesh repair, involves fixating mesh onto the closed abdominal wall to reinforce the incision and reduce the risk of recurrence. The problem is that current mesh fixation technologies are:
- time consuming and technically difficult;
- unable to rapidly and reproducibly tension mesh; and
- frequently produce uneven, wrinkled mesh, which can lead to suboptimal reinforcement, post-operative complications, and eventual re-herniation.
Paradigm Surgical has developed two main technologies to address these issues:
- the SafeCloseTM Device
- the Dual Tacker Device.
Both devices are hernia mesh fixation tools that directly address the many shortcomings of current mesh fixation technologies. They simplify, standardize, and improve the effectiveness, reliability, and reproducibility of mesh fixation for both hernia treatment and hernia prevention.
The main innovation behind Paradigm’s technologies is that they systematically integrate traditionally independent intraoperative tasks into one system. The surgeon does not have to waste time to go through the technically challenging and cumbersome process of hand-sewing the mesh. Using different techniques for different kinds of surgeries, both the SafeClose and the Dual Tacker automate this fixation process making it faster and more efficient, while also increasing the procedure’s effectiveness.
“Your team has developed an innovative technology that is primed to solve an important issue in the abdominal surgery and hernia field”
The Road to Commercialization
Paradigm has successfully completed Phase I device development and testing for each of its two main technologies, which positioned them to apply for much larger NIH Phase II SBIR grants.
So far, they have received the Phase II grants for SafeClose (with Dual Tracker likely right behind). Using the grants, Paradigm will complete a good portion of formal product development so they can approach the FDA for clearance and eventually begin commercialization. So far, the total Phase I STTR and NIH Phase II SBIR funding for Paradigm is $2,192,604.
“The Dual Tacker, if developed, will be poised to advance the treatment and prevention of hernia and have a major impact on the treatment of thousands of patients.”
Leveraging PCI Programs for Success
The Paradigm team, including Dr. Fischer and Penn alumni Jonathan Sanchez, knew that their best chance for success was to leverage the assistance programs the Penn Center for Innovation created to support startups like Paradigm.
Early on in the company formation process, Dr. Fischer and Jonathan participated in the Penn I-Corps program. The multi-week customer discovery course, helped to iron out Paradigm’s value proposition, customer segments, and most importantly, customer needs – all of which are critical to developing a successful product and company. They bounced ideas off of other Penn startup founders and used the information learned to position themselves to seek grant funding.
At the same time, Paradigm was meeting with the PCI Ventures team for guidance and support. According to Jonathan Sanchez, Paradigm’s Lead Product Design Engineer, “Time and time again, Mr. Dishowitz and the PCIV team steered us in the right direction when it comes to finding project collaborators, hiring key company personnel, searching for funding sources, submitting strong grant proposals, and just overall giving us sound advice at several important points since our company’s inception. They have been an invaluable source of direction and we are all eternally grateful for such a helpful partnership.”
Paradigm is currently working on their Phase II project and finding engineering partners to bring their product to FDA clearance. Contact Paradigm by emailing jsanchez@paradigmsurgical.net.
“Innovative techniques and technologies like the SafeClose are of tremendous potential.”