In November I wrote a comprehensive article for Medium about a potentially groundbreaking medical technology called Healight™ultraviolet light technology platform (“Healight™”). Many experts believe that Healight™ has the capacity to become a first-in-class treatment for severely ill patients intubated in the Intensive Care Units (“ICU” ) and in the near-term as a COVID-19 treatment for those most critically ill COVID patients.
A Colorado-based biopharma named Aytu BioScience (“Aytu”) received the global license for Healight™ from Cedars-Sinai Medical Center last April. Aytu CEO and Chair Josh Disbrow recently referred to this technology as the equivalent of a “moonshot” because of its potential.
“We see broad potential application well beyond Healight’s use in COVID. [it] has the potential for significant use in other conditions, including ventilator-associated pneumonia (VAP), severe influenza, and other infections. As UV light is agnostic, so to speak, to the pathogens it kills and is so different in the way it does it, the antimicrobial applications for Healight are broad,” Mr. Disbrow told a conference in October.
Healight™, as the previous article explained in-depth, is a novel endotracheal catheter emitting ultraviolet light that has demonstrated broad antimicrobial activity in published preclinical studies. Back in October the FDA had approved Healight™ for clinical trials involving humans under the leadership of Cedars-Sinai, called simply: “UVA Light Device to Treat COVID-19”. This initial small-scale trial involved five COVID-19 patients who were on ventilators to see if it will lessen their viral load and disease severity. During an earnings call on November 12th, Mr. Disbrow mentioned that in the Cedars-Sinai trial, one patient had been treated with Healight™, recovered from the severe Covid-19 effects, and was released from the hospital.
On December 28th, Aytu issued a press release that confirmed Cedars-Sinai had actually concluded the initial feasibility study on the five patients and are working on the next phase to enroll another, much larger cohort of patients for further testing before they publish their findings. It is expected that given the recent surge in Covid-19 cases in the Los Angeles area where the trial is located, Cedars-Sinai will be able to complete enrollment very quickly.
In a recent interview, Mr. Disbrow was pressed on the sensitive and confidential subject of Healight™, and was very careful in providing some encouraging news:
“We’re extremely excited about Healight and every step of the way we get more excited, but we are extremely, extremely constrained with respect to communication around any progress. And that’s just the nature of dealing with an institution the caliber of Cedars-Sinai. When you negotiate things like communication rights, PR, and the ability to utilize their name and showcase what is happening, the bottom line is we just don’t have a lot of latitude there.
That said, again without being specific, I couldn’t be happier about where things stand and what Healight is shaping up to look like. The bottom line is, we’ve got something with Healight and the FDA obviously is an important role player here. Whether we announce it in January or March or sometime later, my commitment is to update as soon as we practically can. The publication schedule will drive a lot of what I’m able to say and when what I hope I’ll be able to at least report our progress on the initial five [patients].”
Zach Burden is in Clinical Engineering at the University of Washington Medical Center in Seattle, Washington. He has been following the development of Healight™ closely and was pleasantly surprised by the pace and progress the Cedars-Sinai trial was reporting.
“What that all means is that Cedars-Sinai was able to treat the remaining four of the five patients in a 17-day period. Whether it was start-to-finish or otherwise, this gives us an idea of how fast the Healight treatment process takes. If Cedars-Sinai began recruiting for the study in early October, it took them roughly two months to both enroll enough participants and complete the feasibility trial. With all the extra work involved in getting the trial started (i.e. receiving the prototypes, training, paperwork, coordinating with the FDA, etc.), enrollment was likely to complete by early-to-mid November, aligning with the timeline of the known first patient being treated and recovering.
If Cedars-Sinai completed the subsequent, larger patient trial enrollment by early-to-mid December, they may actually be in the final stages of data acquisition now, assuming that no equipment modifications or trial adaptations were required and that they are still primarily testing for Covid-19 and not VAP.”
The question then becomes: will Cedars-Sinai divulge (or allow Aytu to share) any of the raw data prior to completing the formal publication? If not, how long does publishing the findings take? If the findings of this trial are positive enough that Healight™ receives Emergency Use Authorization (EUA) from the FDA for Covid-19 treatment, it is assumed that Aytu will still have to perform separate trials for other endpoints prior to commercialization for those other indications.
Mr. Disbrow envisions Healight™, if successful, to become an important tool in hospital ICUs around the world for years to come. One use for Healight™ mentioned by Mr. Disbrow is in the previously mentioned Ventilator Assisted Pneumonia (VAP), with between 250–300k cases a year in the US alone.
William Hoskins, DO, is the Director of Otolaryngology at Pikeville Medical Center in Pikeville, Kentucky. He too has been very interested in Healight™ for its potential as a huge breakthrough treatment for use in his practice and profession.
“VAP is deadly in the short term, particularly for long-term intubated patients, so if the studies show it’s safe it would make sense to deploy it even if long-term effects of this novel treatment won’t be known for awhile. I don’t see an ET tube with a built-in Healight as necessarily invasive. Definitely a valid concern but these are critical patients. They, their family and their physicians are less concerned with long-term effects in these situations. It should also be easier to recruit for VAP than covid as all you would need is an intubated patient.
Hospitals lose tons of money due to VAP because they don’t get paid if a patient contracts it. Therefore if Healight is as cheap as we think it might be, it will be a cost-effective preventive measure and likely its primary objective. Everything else is just a bonus in my opinion,” Dr. Hoskins opined.
Dr. Hoskins believes Covid ICU’s will be the first to receive Healight™. He also feels that Cedars-Sinai will likely conduct a VAP study for Healight™ concurrently to expedite further deployment beyond Covid.
“That’s the gold mine. Once the indication is approved, all ICU intubated patients would use Healight. When that happens the floodgates will open. We’ll see studies for acute pharyngitis and sinusitis. Urinary indications could be a second gold mine. I hope to one day use it intraoperatively for sinus surgery,” Dr. Hoskins said.
Along with the details of the trial and the time frame for when Healight™ will be available to the first clients, other important questions surrounding this breakthrough medical technology, include whether Healight™ is going to be a stand-alone accessory to the ventilator? With the endotracheal tube market estimated to hit $3.2 billion by 2026, the opportunity to integrate Healight™ into those products could be huge.
“I think we have a really good shot of turning this into a really nice company and that’s before you even think about how we maximize the value of Healight and how we monetize that; whether that’s through a spin-out or we operate it ourselves. Frankly, it wouldn’t take a very large sales force to commercialize the medical device that has the capabilities that Healight does,” said Mr. Disbrow in a recent interview.
According to The 2019 National and State Healthcare-Associated Infections Progress Report,
“Healthcare-associated infections (HAIs) are complications of healthcare and linked with high morbidity and mortality. Each year, about 1 in 25 U.S. hospital patients are diagnosed with at least one infection related to hospital care alone; additional infections occur in other healthcare settings. Many HAIs are caused by the most urgent and serious antibiotic-resistant (AR) bacteria and may lead to sepsis or death. CDC uses data for action to prevent infections, improve antibiotic use, and protect patients.”
If Healight™ can be effective in treating any or all of the top HAIs, it will become a truly revolutionary invention used in every hospital setting and live up to its billing as a “moonshot” and a giant step for humanity and the healing profession.