Generex Biotechnology Corp.’s wholly owned subsidiary Nugenerex Health partnered with Worldwide Digitech (WWDT) LLC to create a 50/50 joint venture, Nugenhealth LLC. The new company will draw on WWDT’s software to develop an end-to-end software-as-a-service (SaaS) solution for chronic care management using remote patient monitoring.

“We’ve had to rethink some of the areas of business we’re in and be like a chameleon and put the infrastructure we have in place to good use,” said Generex President and CEO Joe Moscato in an investor call.

“Right now it’s all about telemedicine, it’s all about remote monitoring because of the pandemic situation and because the federal government as well as the states now have put in big dollars to be able to take care of patients from a home setting,” said Moscato. “We jumped into this business – why? Because we have the patient populations, we have the doctor partners, and we have the networks to get this program up and running.”

New CPT Codes released by CMS in 2019 provide an incentive for physicians to increase remote patient monitoring to improve management of chronic conditions. Recent rule changes also reduced barriers to partnerships between providers and health tech companies which provide the services, software and monitoring devices required for a successful remote patient monitoring program.

The joint venture with Worldwide Digitech allows Generex to jump into remote patient monitoring and provide improved service to patients and physicians in its networks.

“We have evaluated a number of software systems and companies that claim to deliver the care coordination services, but the WWDT SaaS system far surpassed the others in terms of functionality, connections with electronic health record systems, real-time remote monitoring capabilities with connected health monitoring devices, protocols for RPM and CCM, and a fantastic user interface,” said Moscato.

The new venture will get a boost from the company’s pre-established distribution network. “This program can immediately start giving real results, not only for doctors, not only for patients, but for Generex income streams,” Moscato asserted.

“We plan to launch the system with primary care and endocrinology clinics in Arizona to begin generating revenues as we launch the company,” Moscato added. The revenue from Nugenhealth’s web-based patient care may also help the company revitalize its physician networks.

The company has been setting up its Arizona network for the last four years, in recognition of the state’s position as the third largest Medicare market in the country. Currently, Generex has partnerships with three primary care practices and one of the largest endocrinology clinics in the country, with a combined 50,000 active Medicare recipients across all the practices, said Sanjay Kumar, of Nugenerex Health’s multi-specialty Management Services Organization.

On the call, Kumar outlined plans to spread the MSO to Florida and California, followed by Oklahoma, Texas and four other states. “I am very confident that we will be one of the top four or five remote patient monitoring companies in the country,” Kumar said.

Other developments

In addition to the joint venture, Moscato and other executives of the Miramar, Fla.-based company discussed additional recent developments, including a response from the U.S. FDA to the company’s pre-IND briefing package for its Ii-Key-SARS-CoV-2 vaccine.

The FDA provided a “very detailed response. Overall, the protocol design was approved by the FDA. We do not have to do any toxicology work. That is a major step,” said Richard Purcell, head of research and development. The company can reference previous clinical trials for the adjuvant, which Purcell called a “very good, positive result.”

“It was a great response from the FDA,” said Moscato, “one of the better ones I’ve seen.” Purcell concurred: “Overall, we have very clear direction from the FDA and now have a clear path forward.”

In addition, Generex reported the signing of letter of intent with a potential Chinese partner to develop the Ii-Key-SARS-CoV-2 vaccine for the Chinese market, which has potential to add $400 million in vaccine revenue to the company’s bottom line. Generex also recently heard encouraging news from Health Canada about moving forward with a vaccine for that country and signed a non-binding memorandum of understanding with partners in Malaysia to develop and commercialize the COVID-19 vaccine for that market, for an estimated $150 million.