Linear Health Sciences

easy to do. But when they have this problem, they can be quite difficult.”

The two-piece device consists of a plastic handle that remains outside of the body and a balloon that is placed inside the body cavity. The handle snaps over the colonscope so that it doesn’t have to be removed from the body and reinserted.

The intellectual property is protected by two “very broad” patents.

“The technology BPEndo is developing solves a critical problem physicians face when performing colonoscopies,” said i2E Venture Advisor Rick Rainey, who has worked closely with Dr. Holbrook along his entrepreneurial journey.

“New medical products like this tend to have favorable partnering or acquisition events with large manufacturers looking to bolster their current product offerings,” Rainey said.

BPEndo’s technology appears so promising that the company attracted 13 gastroenterologists as early investors. Both of Dr. Holbrook’s physician partners at Norman Endoscopy Center are investors.

“They know there is a problem, and this may be a good solution,” Dr. Holbrook said. “It’s been really well received.”

In addition to investment by medical professionals, BPEndo received a $1.2 million seed round investment in 2019 that was led by i2E.

As the device nears FDA approval, Dr. Holbrook anticipates another investment round that will facilitate manufacturing and sales. He continues to work closely with Rainey and his i2E colleagues.

“i2E took a lead role in structuring the initial deal and valuation, discussing with me dilution and what my part would be, things like that,” Dr. Holbrook said. “I really relied heavily on their expertise and legal expertise to walk me through this whole process.”

With expected FDA approval looming, there is anticipation of big things ahead for BPEndo and its founder.

“If you just do the simple math, that’s at least 2 million colonoscopies that will need this device,” Dr. Holbrook said. “I’m excited about the future.” BPEndo.org

LINEAR HEALTH SCIENCES DEVICE SECURES FDA CLEARANCE

Oklahoma City-based Linear Health Sciences has received U.S. FDA clearance and Health Canada approval of its Orchid SRV™, a tension-activated breakaway safety release valve designed to reduce the risk of IV catheter failure and replacement in hospitals.

The medical device company also announced the simultaneous launch of Orchid SRV Type D, a Class I device based on the same proprietary platform technology for use in surgical/wound, nephrostomy, and abscess drainage.

The Orchid SRV is a sterile, single-use connector for needlefree access that, when activated, makes return to treatment fast, simple, and clean, while improving both the patient and clinician experience. Clinical simulation testing of 360 Orchid SRVs showed that the device prevented IV dislodgement by 91.1 percent across all test groups. The Orchid SRV is indicated for use during direct injection, intermittent infusion, and continuous infusion.

“We designed Orchid SRV to disrupt an area of medicine long overlooked and due for positive change,” said Dr. Ryan Dennis, Linear Health Sciences co-founder and CEO. “We expect our current and future pipeline of platform technology-based products to help change the standard of practice in vascular access and medical tubing applications as a whole.”

Orchid SRV is placed between the existing IV extension set and general IV tubing connection intended to be used for delivery of fluids to and from an IV catheter. When tension (of up to 3.25 lbs.) acts on the IV line, the valve separates and seals off both sides of the IV, creating a sterile barrier. The clinician then restores the line simply by removing the separated halves and replacing them with a new, pre-packaged, sterile valve. According to a study published in J-AVA, 95 percent of 1,561 U.S. clinicians surveyed agreed that IV dislodgements continue to pose significant safety risks for patients and hospitals. In fact, reports have shown that, of the 342 million peripheral IVs in the U.S. each year1, up to 10 percent may dislodge2, costing more than $2 billion annually3. Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens.

“Despite great advances in other areas of medicine, there is still a significant unmet need for improved safety in IV therapy,” said Nancy Moureau, PhD, RN, CRNI, CPUI, VA-BC, an internationally recognized expert in vascular access practice who conducted the survey. “With an estimated 90 percent of hospitalized patients requiring treatment using IV therapy and a need to maintain those devices, it is time for a product like the Orchid SRV, not only to increase patient and staff safety but also to reduce cost associated with accidental dislodgment.”

“The power of our breakaway safety release valve technology platform has been demonstrated and is now validated by both the FDA’s and Health Canada’s clearance of the Orchid SRV,” said Dan Clark, co-founder, president, and COO of Linear Health Sciences. “Our platform expands with the addition of Orchid SRV Type D, and we look forward to developing new use cases for it in other areas of medical tubing in the future.”

Dr. Ryan Dennis

Linearsciences.com

In 2020, Plains Ventures, a subsidiary of i2E, led an $11.535 million Series B investment in Linear Health Sciences. It was a follow-on investment to a 2016 Seed round investment of $1.25 million and a $1.54 million Series A round in 2018, both of which were led by i2E/Plains Ventures.

References: 1 iData research report 2 "The Peripheral Intravenous Catheter Journey: A Prospective Cohort Study of 1000 Patients." Podium presentation by Nicole Marsh, RN, and Claire Rickard, RN, PhD, AVA 2017 ann 3 Helm, et al. “Accepted but unacceptable: peripheral IV catheter failure” J Infus Nurs May-Jun 2015;38(3):189-203. doi: 10.1097/NAN.0000000000000100