To sell in the US market, every foreign company needs the support of locals. For medtech company Singular Health Group (ASX: SHG), that is Kelyniam Global Inc. The Company has appointed Kelyniam as its US-based agent—a key appointment and integral pre-requisite to satisfy the final FDA regulatory requirement, prior to Singular Health entering the US.
In late October this year, the Company’s 3Dicom software received FDA approval to be sold as a Software-as-a-Medical Device (SaMD) in the country.
In keeping with that, the Company is already executing its marketing strategy. It has teamed up with CG1 Solutions, a Florida-based medical IT consulting service. CG1 will join the recently formed 3Dicom Partner Program to help sell Singular Health’s 3D MRI and CT scan solutions. With the help of CG1, Singular Health plans to sell its 3Dicom products in US hospitals.
The appointment of Kelyniam was a necessity for the Company. FDA laws require that every foreign company receiving an FDA must have a US-based agent. The US business acts as the in-country point of contact and liaison on regulatory filings, product updates and other requirements before the foreign company can sell in the US market.
Singular Health’s CEO, Thomas Hanly, commented, “After engaging with Kelyniam’s team on our cranial AI model and various initiatives through 2022, we’ve witnessed first-hand their deep in-country expertise and particularly the calibre of their Leadership team. We welcome them as our US-agent and will continue to work towards further strengthening the ties between our companies.”
No doubt, Singular Health has done some serious work to make its presence felt in the US. As per its report, 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.
Moreover, Kelyniam’s customer base of surgeons and a well-incentivised sales force is an added bonus for the Company. It will help gain traction for its 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.
The 3Dicom Partner Program targets medical device manufacturers and med tech companies to sell and promote the product. In keeping with that, CG1 Solutions was identified as a founding member of Singular Health’s 3Dicom Partner Program based on its shared vision of improving patient-specific outcomes through technologies. Plus, that it had an existing presence in the US healthcare market providing services to large hospitals and clinics was super beneficial.
Both companies are currently trying to provide patient education solutions with 3Dicom in US hospitals and clinics. Under the 3Dicom Partner Program, partners are not currently bound to minimum sales volumes and each party incurs its own costs.
CG1 Solution’s Managing Partner, Edwin Rivera, shared, “Singular Health’s technology, particularly the 3Dicom Viewer, provides the next level of interaction and engagement. We see this application, which allows MRI and CT scans to be viewed in 3D, as being the new standard in the industry and that is why we are thrilled to be a partner.”
With the FDA approval secure, both shareholders and the Company are excited to see what Singular Health’s year is going to look like.
Alinda is a Business Reporter for The Sentiment
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