Bioinduction Announces the World's First Successful Implantations of 'PICOSTIM', a Novel, Less Invasive, Self-Contained Cranialized 'Brain Pacemaker' for Parkinson's Disease

Small, smart, single-stage skull implanted DBS system can be implanted in under half the time of conventional implantations

BRISTOL, England, June 30, 2021 /PRNewswire/ -- Bioinduction Ltd., a company developing an innovative and disruptive patient-centric Deep Brain Stimulation (DBS) platform solution designed to treat cerebrovascular and neurodegenerative diseases, announces the world's first implantations in patients with Parkinson's disease.

DBS is the gold standard late-stage Parkinson's treatment with worldwide regulatory approval, but adoption remains limited to ~5% due to procedure complexity and cost. The Picostim™ DBS system, developed by Bioinduction, is the world's first miniaturized precisely targeted "brain pacemaker" that is implanted directly into the skull, making it cosmetically invisible. Being a third of the size of conventional DBS devices, it eliminates the need for extension leads, neck tissue tunneling, chest incision and a pocket for the battery.

A simpler, less invasive, single-stage intra-operative fully cranialized implantation workflow harnesses state-of-the-art, image-guided planning, navigation, and surgical-robot assistance, together demonstrating the future of brain pacemaker interventions. The result is less time in surgery for patients and elimination of the need for revision surgery for lead or extension wire fractures. Uniquely, Picostim™ also provides a wireless recording of brain signals without the cardiac artifacts associated with chest implantation, potentially helping clinicians to optimize treatment and monitor outcomes.

The device is currently undergoing a clinical trial that has been designed to evaluate the safety and efficacy of the Picostim™ system for Parkinson's disease, with four patients implanted to date. This clinical trial^[1] will recruit up to 25 patients.

Ivor Gillbe, co-founder of Bioinduction, stated: "Bioinduction's mission is to enable a paradigm shift in the world of DBS implantations for those with chronic brain disorders. The team and partners have delivered a major milestone in the development of the next generation of elegant, evolutive cranialized brain pacemaker platform. Picostim™ harnesses state-of-the-art innovations and research enabling new possibilities to address significant unmet needs, initially focused on Parkinson's disease. We look forward to completing the pivotal CE mark study and bringing Picostim™ to the market, as well as expanding the clinical program for significant unmet needs in cerebrovascular and cognitive disorders."

Contacts:

Ivor Gillbe: Ivor@bioinduction.com

Khalid Ishaque khalid@bioinduciton.com

Telephone: +44 117 987 4100

@Bioinduction

ABOUT DEEP BRAIN STIMULATION AND PICOSTIM^TM

Deep brain stimulation (DBS) is an approved, safe, and effective treatment for patients with Parkinson's disease that cannot be adequately controlled with medication. DBS is the gold standard late-stage Parkinson's treatment with worldwide regulatory approval, but adoption remains limited to ~5% due to procedure complexity and cost.

DBS involves surgically implanting electrodes in specific regions of the brain that are connected to an implantable device, similar to a pacemaker. Over 200,000^[2] people worldwide to date have received DBS systems.

The Picostim™ DBS system is the world's first miniaturized skull-mountable system, the IPG being one-third of the volume of conventional DBS devices. The rechargeable device is capable of meeting and exceeding conventional chest-mounted device functionality.

Skull implantation eliminates the need for tunneled extension leads. Up to a quarter of DBS patients have experienced circuit discontinuity and subsequent therapy interruption with studies showing up to 5.1%^[3] of patients needing revision surgery for lead or extension wire fracture.

Employing the best available technology and practice, the implantation for a chest-mounted IPG can take five to seven hours^[4] of surgical time in a multi-stage procedure. Picostim™ can be implanted in a single stage, without removing the stereotactic frame used to accurately position the electrodes, allowing for a more streamlined surgical workflow. The Picostim™ DBS system has been designed to enable a faster, single-stage implantation procedure, eliminating extension wire tunneling, reducing the risk of pain, irritation, infection, and lead breakage.

This elegant platform has been designed to evolve by integrating novel smart features, including scheduling motion responsive stimulation, and developments to further integrate real-time closed-loop features to be evaluated in future clinical studies.

ABOUT PARKINSONS DISEASE (PD)

Parkinson's disease is a progressive neurodegenerative disorder that can lead to tremor (trembling), stiffness, slowness of movement and poor balance, amongst other symptoms. Parkinson's disease occurs when nerve cells, or neurons, in the substantia nigra, an area of the brain that controls movement, become impaired and/or die. There are an estimated 145,000 people in the U.K. living with Parkinson's and 10 million people worldwide. Men are 50% more likely to be affected. The cause is poorly understood and there is no cure.

ABOUT BIOINDUCTION LTD.

Bioinduction's mission is to revolutionize the treatment of cerebrovascular and neurodegenerative diseases where there is no effective drug therapy available today. Diseases of cerebrovascular origins such as resistant hypertension, stroke, Alzheimer's disease and vascular dementia rank alongside cancer as one of the greatest healthcare challenges faced by humanity, affecting one in three in later life. Currently, there are no efficient treatments proven to modify the course of these diseases. Bioinduction has developed a precisely targeted brain pacemaker that offers new hope for millions of sufferers.

Bioinduction is the only UK-based ISO 13485-approved manufacturer for active implantable medical devices including clean room facilities.

For more information, visit: www.bioinduction.com.

Follow us on: @bioinduction and https://www.linkedin.com/company/bioinduction-limited/

[1] SPARKS trial | https://clinicaltrials.gov/ct2/show/NCT03837314 

[2] Front. Hum. Neurosci., 2021 | https://doi.org/10.3389/fnhum.2021.644593 

[3] Operative Neurosurgery, 2020 | https://doi.org/10.1093/ons/opaa215 

[4] Stereotact Funct Neurosurg, 2013 | https://doi.org/10.1159/000343207