BIOFEST INVEST APPLICANT

Bexar Biomedical, LLC

Company Contact:

Legal Entity Type: LLC

Company Type: Medical Device

Company Stage: Feasibility

No. of Employees: 5

Desired Financial Amount: $256,000 followed by $1,000,000.

Background

Company Background

Bexar Biomedical, LLC is a new medical device company focused on a drug delivery device and new drugs for pain management. The device is a new, small implantable medical infusion pump for intrathecal (subarachnoid) delivery of spinal drugs for pain relief. The first device of this type was designed, built, tested and FDA cleared for pain management in 1984. The original implantable pump, branded the “Infusaid” pump, about the size of a hockey puck, was sold to Pfizer. Two of the members of Bexar Biomedical, LLC were on the original development team for this new smaller, lighter device. Our mission is to scale down the size of this “mini pump” to roughly 1/3 the size of the hockey puck. This will allow implantation adjacent to the iliac crest, and shorten the distance to the lower spine. The original and still used larger pumps must be implanted in left or right lower quadrant of the abdomen with the catheters tunneled from there to the lower spine. Benefits of our new Mini Pump in addition to our smaller size include non-metallic components, lighter weight, less noticeable, and lower cost of manufacture.

Management

Doug E. Frantz, PhD Distinguished Professor & Chair of Department of Chemistry, UTSA Merck Research Fellow worked on blockbuster drug Januvia R. Lyle Hood, PhD Assistant Professor of Mechanical Engineering, UTSA Serial entrepreneur published expert drug delivery, nanomedicine, interventional medical devices, & micro-electromechanical systems Ralph Johnston Executive positions: Elan, Pfizer, Genzyme and Corning Led the worldwide development of implantable drug delivery systems for pain, oncology and diabetes Paul Fenton R&D & Ops Mgt.: Pfizer, Tornier, CR Bard – PCA pain pumps, intrathecal implants – 75 patents – Founder venture capital backed companies with successful exits

Board of directors

Above Members comprise the current board

Product / Service

disease area / application

Pain management

product / Service

Bexar Biomedical, LLC is a new medical device spinoff from the University of Texas San Antonio. The company is developing a new, totally implantable intrathecal drug delivery pump for pain management. The current standard of care include three implantable pumps which are all larger, more complex, significantly more expensive and more complicated to operate. Their life span is limited to 2-3 years due to the shelf life of the onboard battery. The Bexar Biomedical Intrathecal Infusion mini pump is a smaller, lighter, non-metallic device which has only a single moving part, the bellows. It will made of a composite material which will be implanted near the iliac fossa in the hip. The short drug delivery catheter will be tunneled from the pump to the intrathecal space in the lower back.

technology / ip

We have submitted two patents currently with additional IP to follow. The size, materials, infusion characteristics will all be patented.

distribution channels

Bexar Biomedical will hire, train, and support a direct sales force. In addition we will partner with national companies that provide home health care to pump patients including refilling the pumps. One company in Austin currently supports about 3000 patients in the U.S.

market size

Pain management is among the “Top Ten” recognized global healthcare issues. Medical devices have the potential to play a pivotal role in tackling the opioid crisis while also providing patients a convenient mechanism for their own pain management. Medical devices In 2016, an estimated 20.4% of U.S. adults had chronic pain.

competition

Three companies currently control the implantable pump market; Medtronic Synchromed device, Flowonix with Prometra and Intera with the Intera 3000 oncology pump. These devices are all metal, require batteries to operate (except for the Intera 3000) are heavy and must be implanted under a laparotomy. One advantage that Medtronic and Flowonix have is a programmable flow rate that can be used to change the dose infused. The Bexar Biomedical pump will be filled with a prescribed dose.

Financials

Desired financial amount

$256,000 followed by $1,000,000.

previous funding

Current founders have invested $20,000.

current financials

The company is pre-funding; we have submitted both an NSF and NIH (pending) grants. We currently have about $15,000 on hand.

financial use

This funding will be used to initiate development of the device. We will achieve a prototype in Phase I and apply for FDA clearance in Phase II. We will begin with drugs currently approved for intrathecal infusion; morphine, baclofen, and ziconotide.

revenue

Initial sales will come from our clinical trial centers and referral from centers known to the founders. This includes the military and VA.

exit strategy

We plan on a two-pronged approach. Initially we will develop, gain regulatory approval and sell the mini pump directly. We plan to add new drugs to this device and possibly license this to the pharmaceutical company. In addition we plan to carry on with the device for other new drugs that will benefit from direct intrathecal infusion.

Pitch Video

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