Medical technology company Singular Health Group Ltd (ASX: SHG) has appointed Kelyniam Global Inc. as the company’s US-based agent, a key appointment and important pre-requisite to satisfy the final regulatory requirement, prior to Singular Health making sales in the US.
Singular Health has also announced that CG1 Solutions, a Florida-based, well established medical IT consulting services company providing solutions to US hospitals, has joined the recently formed 3Dicom Partner Programme. CG1 Solutions will shortly commence promoting the diagnostic 3Dicom MD software for sale into US hospitals.
These key appointments follow presentations by Singular Health’s COO, James Hill, at the Southern Neurosurgical Society (SNS) 2022 Conference in March, and American Association of Neurological Surgeons (AANS) in May, and by Dr Guan Tay, Executive Director of Research and Innovation, and Dr Martina Mariano, Global Partnerships Manager, at the MedTech conference in Boston in October, highlighting the success of Singular’s ongoing outreach in creating global recognition for the Company and its products.
Appointment of US-based Agent – Kelyniam Global
Kelyniam Global Inc, a Connecticut-based medical device manufacturer involved primarily in patient-specific cranial implants, has been selected as the company’s US-based agent due to their current management’s recent exceptional track record, highly skilled and flexible team, and strong reputation in the US patient specific implant market.
The appointment of a US-based Agent is required by the FDA for all foreign entities, to act as the in-country point of contact and liaison on regulatory filings, product updates and other requirements, prior to making sales in the US market.
Receptive to new technologies and with a well- established customer base of surgeons and well- incentivised sales force, Kelyniam is also very well positioned to both provide continual feedback on the 3Dicom Surgical software and AI cranial implant tool (under development), 3Dicom MDTM software (now diagnostically certified), and 3Dicom Patient with the soon-to-be-released Mobile App.
Founding Member of Partner Programme – CG1 Solutions
CG1 Solutions, a Florida-based IT medical consulting company, has recently joined Singular Health’s newly established B2B “3Dicom Partner Programme” and will be marketing both the non-diagnostic and diagnostic 3Dicom software offerings to their existing customer base, and conducting joint marketing activities with Singular Health at upcoming tradeshows and conferences.
Singular Health’s 3Dicom Partner Program, run by Dr Martina Mariano, will see a focus on engaging with medical device manufacturers and digital health and medical technology companies to promote, market, and integrate Singular Health’s 3Dicom software on a global scale, complementing and leveraging the direct-to-consumer channel.
Operating through discounts and commissions, the 3Dicom Partner Programme greatly reduces capex requirements for Singular Health to enter the US market, whilst providing strong financial incentives for 3Dicom Partners to actively commercialise the 3Dicom software whilst offering additional benefits through the diversification of their product offerings and ongoing revenue streams.
CG1 Solutions was identified as a founding member of Singular Health’s 3Dicom Partner Program based on their shared vision of improving patient-specific outcomes through technologies, along with their existing presence in the US healthcare market providing services to large hospitals and clinics. CG1 Solutions and Singular are currently pursuing opportunities to provide patient education solutions with 3Dicom in US hospitals and clinics. Under the 3Dicom Partner Program, Sales Partners are not currently bound to minimum sales volumes and each party incur their own costs.