TheraLase Technologies Inc (CVE:TLT, OTCMKTS:TLTFF) has developed laser products to heal tissue and treat pain, although its long-term value probably lies with an early-stage, light-activated treatment for cancer.
Unlike many fledgling med-tech companies it is generating revenues and thinks there is scope to significantly increase turnover in the next few years. A market capitalization of $43mln suggests investors are yet to fully recognize the huge potential of this hybrid business.
Therapeutic Laser Technology
This is cold laser technology that uses light to penetrate tissue to promote cellular regeneration at the source of the injury. It effectively heals patients by eliminating pain, reducing inflammation and accelerating tissue healing.
The equipment is used by doctors and other healthcare professionals and the company has around 600 TLC-1000 systems installed in Canada and 400 a further in the US and internationally.
The TLC-2000 is its next- generation product backed by eight patents. Last year its kit, which is leased out, generated sales of $2mln. However, chief executive Roger Dumoulin-White reckons there is room for exponential revenue growth.
“If you look at the Canadian and US market, so you’re looking at doctors, chiropractors, hospitals, physical therapists, you know, that type of grouping of individuals, there’s about 1.65mln in North America or in Canada and the United States,” Dumoulin-White said in a recent interview with James West of the Midas Letter. “So at an average sale price in the $25,000 range, it quickly runs into the billions of dollars of potential for the technology.”
The TheraLase boss thinks the business could be generating $30-$50mln annually in the next three to five years.
Photo Dynamic Therapy
The company is developing light activated photo dynamic compounds (PDCs) to destroy cancer. This is where the compound is absorbed by the tumour and activated by light.
A phase Ib clinical study in Canada for non-invasive bladder cancer was expected to commence in the fourth-quarter of last year focusing on a small group of patients.
The first-in-man study of TLD 1433, a water-soluble molecule, is designed to assess safety and tolerability rather than efficacy.
A catheter will be used to fill patients’ bladders with the drug, which is left in situ for 60 minutes to allow it to localize into the cancer lesions.
The area is then flushed before a fibre optic bundle is inserted to illuminate the bladder with a green laser light. This activates the drug that destroys the cancer.
While uncomfortable, it is far less painful and invasive thaAnd a major milestone has now been reached.
First patient treated....
On April 4, the firm said that the first patient was treated on March 30 for non-muscle invasive bladder (NMIBC) cancer using lead compound TLD-1433.
Chief executive Roger Dumoulin-White said this "significantly" de-risked the company "by shifting it from a pre-clinical to now a clinical biotech organization in oncology".
"Theralase looks forward to successfully treating the next 2 patients and reporting out on the status of the first three patients in the study in 2Q2017," he said.
The next two patients have been enrolled in the study designed to treat three patients at a lower dose and to monitor the patients for 30 days.
If successful, then six more patients will be enrolled to be treated at a higher dose and monitored for 180 daysn the alternative treatments, which have patchy success rates.
“It’s very, very exciting technology if we can make this work,” said Dumoulin-White.
Investigational new drug application.
Later, TheraLase expects to move the research and development process up a gear with an investigational new drug application to the Food & Drug Administration for a Phase II clinical study in the US.
While it is still early days for the technology, peer-reviewed preclinical results have been impressive.
“The drug has performed beyond our expectations as far as safety, tolerability and efficacy,” said Dumoulin-White.
“We’ve seen virtually 99 to 100% kill across a wide range of cancers.
“We’ve tried this on brain cancer, breast cancer, colorectal cancer, pancreatic cancer, prostate cancer. Same results: 100% kill, virtually no toxicity to healthy tissue.”
Researchers have even seen what’s called an immune-mediated response. That means the laser-activated drug has prevented the recurrence of cancer by teaching the immune system how to recognize the signature of those cancer cells.
“So, it’s a very exciting technology,” said Dumoulin-White.
“Having said all that, everyone’s head over heels about it, the scientists, the peer reviewed publications, our scientists and clinicians.
“Having said that, we haven’t tried it humans yet.”