"As an early stage medical device company, we used NIH SBIR funding to hire employees and help us patent and commercialize devices, which set-off a domino effect. As the company grew, we were able to hire more people and create additional products to help patients. Without NIH SBIR funding, we’d likely never have survived."
– John Fisher, M.D., Fred Ahari, Jim Gibson, Founders of Biopsy Sciences
Biopsy Sciences, LLC is a medical device company founded in 2000 by John Fisher M.D., an interventional radiologist, Fred Ahari, and Jim Gibson. Biopsy Sciences is best known for their lead products, the BioSEAL and the HydroMARK, which have both received NIH SBIR funding, and were wholly-owned subsidiaries of Biopsy Sciences. BioSEAL was sold to Angiotech Pharmaceuticalsin 2007 and HydroMARK was sold to Devicor Medical Products, Inc.in 2014. Biopsy Sciences currently has nine full time employees and is based in Clearwater, Florida.
BioSEAL – Reducing Lung Collapse Rates after Lung Biopsies
Biopsy Sciences was awarded an NIH SBIR Phase I in 2003, and Phase II in 2005 to research biodegradable sealants for biopsy tracts in soft tissues. The research resulted in the BioSEAL, which is a novel biopsy device system that contains a proprietary hydrogel plug designed to prevent air leaks that can lead to a collapsed lung, pneumothorax, in patients having lung biopsies. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture. The plug is absorbed into the body after healing of the puncture site has occurred. The end users of the technology are interventional radiologists conducting lung biopsy procedures.
BioSEAL Achieves Clinical Success through Successful Partnerships
Biopsy Sciences launched into clinical trials with initial trial site support from MD Anderson among others.
The BioSEAL is a biopsy tract sealant, which reduces lung collapse and chest tube placement rates after a CT guided lung biopsy.
In 2007, when the trials were only approximately 50 percent complete, the company was sold to Angiotech, a global specialty pharmaceutical and medical device company. Angiotech expanded the number of clinical trial sites and completed the 300 patient study. The clinical trials aimed to assess the safety and efficacy of BioSEAL, with the primary goal of reducing lung collapse rates in patients undergoing lung biopsy procedures. The trials showed a 50 percent reduction in the incidence of lung collapse rates due to BioSEAL technology in the studied patient groups. In March 2014, BioSEAL received a De Novo 510k device classification from the Food and Drug Administration.
HydroMARK – Decreasing Patient Discomfort with a Minimally Invasive Breast Biopsy Procedure
Dr. Fisher and his team developed the idea for the HydroMARKby injecting a BioSEAL into a chicken breast. After performing an ultrasound after an hour delay, the team noticed that the BioSEAL was remarkably visible after it transformed from a dry hydrogel plug to become 90 percent water after hydration.
Before HydroMARK, breast radiologists would be required to use a mammogram procedure to insert a wire into the breast to locate a tumor. The surgeon would then create an incision at the wire to find and remove the tumor. With the HydroMARK, a mammogram is no longer necessary and the surgeon or radiologist can use an ultrasound to locate the tumor. View a product demonstrationfrom HydroMARK showing how this product works.
Biopsy Sciences received an NIH SBIR Phase I in 2002 to research biodegradable soft tissue markers for breast biopsies. This funding helped Biopsy Sciences advance their product and attract private investors. “Investors aren’t interested until the product has reached a certain stage of development, and you can’t get your product far enough along unless you have money to help you advance your product – that’s where NIH SBIR came in,” says Dr. John Fisher, Founder and CEO of Biopsy Sciences.
HydroMARK was sold through roughly 15 distributors in the US and around 30 worldwide and generated approximately 7 million dollars in revenues in 2013. The product and all rights associated with HydroMARK were acquired by Devicor Medical Products, Inc. in early 2014.
Future for Biopsy Sciences
Biopsy Sciences continues to operate as a fully functioning company even though BioSEAL and HydroMARK have been acquired.
The HydroMARK is a biodegradable hydrogel polymer (above).
After 24-hour hydration in tissue is visible using an ultrasound procedure (pictured below).
Dr. Fisher explained that "Biopsy Sciences has become a kind of an incubator – if we or someone else develops a promising innovative idea that has commercial vitality, we will look at it. As a physician, I am interested in products that help doctors do our jobs better, alleviate suffering in patients and make an overall positive impact. We don’t view commercial success unless our company makes a positive impact on people’s lives," says Dr. Fisher.
Location: Clearwater, Florida
Company Website: http://biopsysciences.com
Information for this success story was gathered through an interview that was conducted by Dr. Lenka Fedorkova, the NIH SBIR/STTR Program Manager and Betty Royster, the NIH SBIR/STTR Communications Coordinator.