Q&A with David Jorden – Nanospectra Biosciences

In the lead prostate cancer indication, the approach to focal therapy must be cognizant of both efficacy and side effects. Prostate cancer is a slow progression disease where the adverse treatment effects of erectile dysfunction and incontinence can be significant drawbacks to patient quality of life. Consequently, the opportunity to ablate a tumor/lesion on a basis conformal to the tumor's shape while sparing healthy tissue (such as vascular nerve bundles and urinary sphincter) offers a significant patient benefit.
Nanospectra’s unique ultra-focal therapy for ablation of prostate tissue will occupy an attractive and important middle-ground between “active surveillance” and the established radical treatment approaches (radical prostatectomy, radiation). Paired with effective targeted fusion biopsy and the ability to properly image and visualize a lesion/region of interest, targeted treatment of the localized disease becomes an attractive option for patients seeking disease treatment and side effects avoidance.
In prostate, approximately 80% of the ~175,000 annual (US only) new prostate cancer diagnoses represent localized disease. Estimates are that up to 40-50% of radical prostate treatments (surgery/radiation) could be viable candidates for effective focal therapy. 5,000 AuroLase treatments are estimated to generate $30 million of annual revenues with only 50-60 practicing clinicians. $60-$100 million of annual revenues (US only) can be reasonably modeled based on the addressable market opportunity.

The capital raised here will complete the pivotal clinical study in prostate and allow the company to submit its de novo 510(k) device application by an estimated late 2nd quarter 2021 timepoint. The full dataset for prostate tissue ablation will meet the FDA's published requirement for treatment of at least 100 subjects. In addition, initial clinical data in the intended second organ site should be available over the next 6-9 months in low risk papillary thyroid carcinoma (PTC). PTC shares many similarities to prostate cancer as it is prone to over-treatment with resulting negative impact on patient quality of life.

The revenue model consists of the sale of consumable proprietary gold nanoshells and a disposable laser delivery device. Customer/facility capital investment is modest and consists of a low power laser device if necessary. Therefore, the cost of entry for a site/practice that wishes to directly understand efficacy and how the technology fits within treatment modalities and practice patterns is almost all variable. This is in comparison to material capital investment required in competing focal therapy approaches - e.g., $500,000 - $1,000,000 to enable high intensity focused ultrasound. AuroShells are manufactured directly by Nanospectra as a core competency at reasonable scale and cost and the disposable laser catheter was also developed by the company and is manufactured by a CMO.