Effective Opioid Response
In the yearlong period ending April 2021, over 100,000 Americans died from drug overdose, the vast majority from synthetic opioids. An estimated 4 million of the 11 million still addicted won’t seek treatment for fear of withdrawal.
Spark Biomedical – a leader in wearable neurostimulation solutions – launched with a vision to solve the opioid crisis. Presented with a pressing need to address the growing opioid epidemic, top minds in the field came together to identify a clear clinical pathway and bring the concept to fruition. As the idea matured, Spark tapped Velentium when it needed a sophisticated design house to scale the technology. Spark also collaborated with Galen Data and Greenlight Guru to help build its Sparrow Therapy System™ – a wearable neurostimulation device for treating opioid withdrawal.
Today, the clinically proven solution offers patients facing opioid withdrawal an FDA-cleared, drug-free, targeted therapy option for tackling this daunting problem. Together, a team of entrepreneurs, medical researchers, and scientists, took an existing concept (neurostimulation technology) and transformed the solution to combat the opioid crisis and support millions of Americans suffering from withdrawal.
Changing Lives for Better World
The Sparrow non-invasive earpiece and patient controller work by stimulating two key nerves on and around the ear that connect to the brain’s central reward, decision-making, emotion, and stress regions. Stimulation triggers endogenous (natural) opioid release known as endorphins, which fill the brain’s vacant opioid receptors that then release dopamine. This neurochemical process helps to reduce or eliminate withdrawal symptoms like nausea, vomiting, tremors, anxiety, high pulse rate and bone/joint aches, among others.
During its journey toward FDA clearance of the adult treatment, Spark discovered that in addition to the millions of adults who suffer from opioid withdrawal, there are 35 thousand infants born each year opioid-dependent – known as Neonatal Opioid Withdrawal Syndrome (NOWS). Knowing the first days of life are a critical developmental period for all infants, the company immediately widened its scope to include NOWS, leveraging its tAN® therapy into a neonate version, the Sparrow Fledgling™. Initial clinical proof-of-concept results exceeded expectations, dramatically reducing the need for morphine in the neonatal detox process and reducing NICU stays by over two weeks. Results were so compelling that the Sparrow Fledgling was granted FDA Breakthrough Device Designation in 2021 to fast-track time to market. Currently, the Sparrow Fledgling device is beginning phase two clinical trial and is funded by a $2.5M NIH Heal Initiative grant.
Over the past 3 years, Velentium has provided critical support to the Sparrow Therapy System™, partnering with Spark during every stage from initial design through final production, in preparation for commercial release. Leveraging solutions provided by Greenlight Guru and Galen Data, the partnership enabled the team to bring the medical device to market in less than two years through rapid development and change management from clinical trial through full commercial production.
Together, Spark and Velentium were recognized for their partnership and were joint recipients of the Houston Business Journal’s 2021 Most Innovative Company Award.
Building a Partner Ecosystem
Spark’s partnership with Velentium, Galen Data, and Greenlight Guru paid dividends almost immediately. Initially, it took 18 months for Spark’s first-gen product to be fully compliant and approved for market. Leveraging Velentium’s design and manufacturing capabilities, Galen Data’s solution for medical device-to-cloud connectivity, and Greenlight Guru’s eQMS, the timeline for the company’s second-gen product was reduced to nine months.
Velentium took over all aspects of design and successfully supported Spark’s limited commercial release (including updating their mobile app for the Apple app store). The team has also stayed on to assist with future iterations of the project, including improvements to the existing unit, a bedside unit that plugs into the wall, the Sparrow Fledgling™ neonatal unit, as well as the second-gen device with immense improvements and optimization based on field feedback.
Disrupting a world where the only treatment choices were more opioids or abstinence that often causes severe withdrawal leading to relapse, Spark’s Sparrow Therapy System™ and its partner ecosystem empower physicians and patients with a fast and effective drug-free, systemic side-effect-free treatment option. Using Sparrow Therapy, 89% of participants experience mild or no withdrawal symptoms at 60 minutes of treatment and sustain relief throughout the detox period.
Headquartered in Houston, Texas with operations globally, Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices for companies of every size and stage, from Fortune 100s to startups. Velentium offers world-class expertise in software, usability, cybersecurity, mobile and cloud, electrical and mechanical development, regulatory, and systems engineering for medical devices. Velentium transforms IP into safe and secure products that will support healthcare professionals, patients, and communities, and ultimately, change lives for a better world. Velentium is ISO-13485 certified and an FDA-registered Manufacturer of Record.
Interested in partnering with Velentium to develop your project? Please contact us at NextStep@Velentium.com and help us fulfill our passion for changing lives for a better world.
For more information, visit http://www.velentium.com.