SPOC pain-locator device, featured recently on 'Today,' receives FDA 510(k)

Developed at Stevens, SPOC device is 'a revolution in pain management'

HOBOKEN, N.J. ¯ A hand-held biomedical device by SPOC (“Stevens Proof of Concept”), developed jointly by students at Stevens Institute of Technology and pain-management expert Dr. Norman Marcus, has just received FDA 510K clearance for manufacture and marketing as a clinical device.

The SPOC device itself, which began life as a Stevens undergraduate Senior Design Team project in 2004, has also spawned a start-up company, SPOC, Inc., which is headquartered in Stamford, Conn. Several young alumni from Stevens are employed by the company, whose tagline reads, “A Revolution in Pain Management.”

“This is a huge step forward for SPOC’s device, SPOC the Technogenesis® Company and Stevens Institute of Technology as a wellspring of great ideas, especially in the area of products that emerge from our Biomedical Engineering program,” said Dr. Helena S. Wisniewski, Stevens’ VP for University Research & Enterprise Development, who is the presiding chair of the SPOC board. “This is a testament to the entrepreneurial education environment at Stevens that we call Technogenesis, where ideas are taken the full cycle, from laboratory innovation to marketplace realization, all the while promoting undergraduate student collaboration in research and development.”

SPOC, Inc. was formed in July 2005 at Stevens by its University Research & Enterprise Development office along with Dr. Marcus, and three Stevens undergraduate students in the Biomedical Engineering program. SPOC’s mission is to develop a proprietary point-of-care medical diagnostic system, consisting of a medical device and methodology that pinpoint the specific myofascial (muscle) trigger points causing pain. SPOC’s diagnostic system will benefit patients by helping to eliminate treatments that prove to be ineffective, such as surgical procedures, and by allowing physicians to locate more effectively and to treat muscles that generate pain.

Since approximately 100 million people in the United States suffer from chronic pain and approximately 80 percent of Americans suffer from some form of pain in their lifetime, the potential market for such a system is enormous.

“Connecticut Innovations is proud to be the lead investor in SPOC. This important technology was spun out of the Stevens Institute of Technology by a team of young undergraduate students. Connecticut Innovations took a risk when it provided start-up financing to the team,” said Peter Longo, president and executive director of Connecticut Innovations, Incorporated. “This technological milestone is significant in that it contributes greatly to the company’s ability to raise additional capital and ensure continued growth.”

“This is an important milestone,” Dr. Vikki Hazelwood, chief executive officer of SPOC, commented. “We are pleased that SPOC has been given a 501(k) clearance by the FDA, and we look forward to the next goals in our plan. Dr. Marcus, Dr. Wisniewski, Stevens, and the alum team of Jeckin Shah, founding student, and Rebecca Apruzzese – a recent Stevens graduate in Biomedical Engineering who joined the SPOC team in 2007 – all deserve the highest praise for their continuing efforts to bring such a needed disruptive-technology product to the American market.”