SBIR-STTR Award

We will develop a cost-effective, a traumatic pulsed dye laser treatment for patients with recurrent respiratory papillomatosis (RRP). RRP is caused by the human papi lomavirus (HPV), and is characterized by recurrent, nonmalignant, proliferative lesions of the larynx. Patients with RRP typically undergo numerous microsurgical procedures to remove laryngeal papilloma threatening airway patency. The standard surgical technique involves C02 laser vaporization of laryngeal epithelium affected by the lesions, and requires general anesthesia. We will illustrate the pulsed dye laser can be used to induce regression of laryngeal papilloma in an a traumatic manner. It has already been shown that the pulsed dye laser is effective in clearing HPV lesions of the skin (verrucae). The Pulsed dye laser radiation is fiber compatible, and may be delivered using a flexible intranasal laryngoscope and focal anesthesia. Potential advantages of the pulsed dye laser treatment over CO laser surgery include (1) reduced morbidity, especially a lower risk of laryngeal scarring, (2) lower cost, (3) reduced technical difficulty, and (4) reduced risk of viral dissemination or transmission.Awardee's statement of the potential commercial applications of the research:10-15 thousand new cases of RRP are diagnosed each year in the US. Because of the long term, recurrent nature of the disease, the number of patient-visits per year for treatment is a considerably higher figure. Commercialization of a reusable laryngoscopic laser delivery system with disposable laser fibers is the objective of the proposed research into an improved treatment.National Institute of Allergy and Infectious Diseases (NIAID)

Laryngeal papillomatosis is a viral disease characterized by the growth of benign tumors in the larynx. The presence of these tumors, or papilloma, adversely affects the voice, and if allowed to proliferate they may cause respiratory failure. The current standard treatment is microsurgical vaporization of the papilloma using a carbon dioxide laser. Disadvantages of the current treatment are primarily a result of the non-specific action of the carbon dioxide laser on soft tissue; in order to completely vaporize the lesion, surrounding normal tissue is disrupted, leaving a wound on the vocal cords. Soft tissue complications such as glottic webbing and other forms of scarring are common. Candela Corporation proposes to develop a new surgical procedure for the treatment of laryngeal papillomatosis based on the selective destruction of lesional microvasculature using a pulsed dye laser. In Phase II, preclinical tests of normal vocal cord physiologic function after pulsed dye laser irradiation will be followed by pilot clinical feasibility studies of the effectiveness of the laser in the treatment of the disease. If successful, the research will lead to a treatment with greatly reduced morbidity, that may be performed under local anesthesia for substantial cost reductions.Proposed Commercial Applications:The proposed research may lead to a cost-effective, safer alternative treatment for laryngeal papillomatosis, and vascular lesions of the vocal cords and larynx.