Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home.

Bengaluru-based medical technology startup Inito on Monday announced that its Fertility Monitor has cleared the regulatory pathway of the United States Food and Drug Administration (FDA). This paves the way for the product’s launch in the US, and also allows access to countries that have signed the Mutual Recognition Agreement with the FDA, it said in a statement. Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home, it said. By measuring two fertility hormones in urine – Estrogen and Luteinizing Hormone (LH) along with AI-based data analytics in the app, Inito said it understands the cycle variations for every individual user, giving highly accurate results unique to every woman’s body.

The US FDA maintains strict regulatory control over all medical devices to ensure accuracy and safety for the end-user. Over the course of more than a year, Initos flagship device has been subjected to a series of clinical studies, manufacturing facility set up tests as per GMP standards, and company-wide quality management system, ensuring the reliability and efficacy of the device. “Inito has always been committed to building a global home diagnostic testing company headquartered out of India, and this milestone takes us one step closer to that ambition. The coming years will see home diagnostics become an integral part of the medical ecosystem, and we’re proud to be among the leaders of this revolution,” said Aayush Rai, Co-founder of Inito. Inito said its patented Flat-lens technology allows dozens of diagnostic tests for fertility, diabetes, Vitamin D and Thyroid, among others, on a single device connected to a smartphone. A study by IIT Delhi determined the device to achieve a 99.12 percent correlation with clinical-grade instrumentations which cost up to 100 times more and are ten times bigger, the statement said.

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Anti-aging as commerce is a steadily growing industry. It is estimated that by 2024, the anti-aging business market will be worth $271 billion.

Most people know that products that purport to halt or reverse aging don’t work or only provide minimal aesthetic improvement. However, that doesn’t stop them from seeking out ever more radical procedures.

In 2016, a company called Ambrosia was launched that uses the blood of the young in a transfusion process to slow aging. The FDA says there is no no evidence that the procedure works.

Numerous science experts and researchers, some of whom had their research used by Ambrosia to further its practices, warn the public that the company’s methods are dangerous.

Nevertheless, Ambrosia now offers the procedure in five American cities and may expand operations depending on demand.
Promises of youth

Ambrosia was launched by Jesse Karmazin. Karmazin is a Stanford Medical School graduate but is not licensed to act as a medical practitioner. Ambrosia offers its youth rejuvenating services via transfusion as an “off-label” medical treatment, meaning that it is an unapproved treatment procedure.

Ambrosia transfuses the blood of people aged 16 to 25 into its customers on the idea that the blood of the young will rejuvenate the internal organs of older people. The company charges $8,000 for one-liter blood transfusions and $12,000 for two-liter transfusions.

Ambrosia conducted clinical trials in 2017 but has yet to share its findings. The company’s product is based on Stanford University research and a 150-year procedure called parabiosis.

The procedure has never been proven to reverse ageing. The recent research conducted on it was to search for treatments for various medical conditions, not anti-aging cures.

The researchers whose work Ambrosia built upon have made public warnings that its anti-aging procedures may be life threatening. They can cause issues with immunity, mismatched transfused blood cells can attack the patient’s cells, and other problems.

The FDA released a public warning about Ambrosia’s procedures without naming the company. Ambrosia halted operations for a few weeks earlier this year but is now operating in San Francisco, California and Tampa, Florida.

The company claims to be operating in Los Angeles, Omaha, and Houston. Ambrosia has reportedly infused over 150 people, aged between 35 ad 92, with the blood of the young.

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