Altair medical achieves FDA breakthrough status

Feburary 24, 2020

Altair Medical, a medical technology company developing a groundbreaking solution to the global opioid crisis, today announce that the US Food and Drug Administration (FDA) has awarded the Company Breakthrough Device designation for its wearable biosensor device.

Altair Medical’s biosensor is a chest-worn wireless sensor that aims to accurately detect when someone is suffering Opioid Indused Respiratory Depression (OIRD), a common and often fatal side effect of using opioid drugs. Causing 1,000 deaths each week in the UK and USA, OIRD is now the largest cause of accidental death in most developed countries.

The technology monitors and analyses respiratory patterns using proprietary algorithms (performance characteristics are not yet established). When it detects OIRD in the patient, it sends a message to designated first responders, or emergency services, who can intervene to administer naloxone. This extemely effective antidote has a very high success rate, reviving the person within seconds.

The Breakthrough Devices Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval. Eligibility is restricted to innovative medical devices that provide more effective treatment or diagnosis of life-threatening conditions, where there are no approved or cleared alternatives, and where early device availability is in the best interests of patients.

To achieve Breakthrough Device Status a panel of experts at the FDA extensively reviewed both its technology and its prospective users. Following the confirmation of this designation, the company will now receive additional support from the FDA, and any submission for US approval of Altair’s technology will be reviewed as a priority.

Jonathan Guthrie, Chairman, said: “This award is a major milestone for Altair Medical in our development and we are currently seeking investment to help us get this important innovation to patients and clinicians who need it as quickly as possible.”

Altair’s founder Dr Bruce Henderson said: “I recognised the need for a new solution to the problem of opiod deaths during my work as a forensic medical examiner. I was appalled at the number of unnecessary deaths and developed the technology to combat this unmet need. Being granted Breakthrough Device status will greatly assist the team at Altair in delivering this life-saving technology to patients.”