SBIR-STTR Award

Non-Invasive Intraoral Led Phototherapy Device for the Prevention and Treatment of Oral Mucositis
Award last edited on: 11/13/2019

Sponsored Program
SBIR
Awarding Agency
NIH : NIDCR
Total Award Amount
$1,709,120
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Vedang P Kothari

Company Information

Lumitex Inc (AKA: Lumitex Corporation)

8443 Dow Circle
Strongsville, OH 44136
   (440) 243-8401
   info@lumitex.com
   www.lumitex.com
Location: Multiple
Congr. District: 16
County: 

Phase I

Contract Number: 1R43DE026082-01
Start Date: 4/1/2016    Completed: 10/31/2016
Phase I year
2016
Phase I Amount
$220,352
?The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral Mucositis (OM). OM is one of the most common and highly significant toxicities of cancer therapy. Approximately 450,000 patients are affected by OM in the United States each year. OM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaks, increased 100-day mortality and a considerable increase in healthcare costs. The standard of care for patients with OM is mainly palliative, aiming to reduce pain, inflammation, and risk of infection. A new, proven, and powerful approach for both treatment and prevention of OM is Phototherapy (PT). Near-Infrared light increases the production of ATP which protects the mucosa from cell death. No reported side effects are observed from using phototherapy for the treatment of OM. Current barriers to the use of phototherapy include the cost of laser equipment, labor intensiveness, inter-operator variability, and inconsistent light penetration. Lumitex PT is developing a flexible, biocompatible silicone light guide to irradiate the entire oral mucosa with therapeutic light. The key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfort and compliance. Our light delivery technology can be integrated into a mouthpiece that safely delivers 4-6 J/cm2 of NIR light directly to the oral mucosa in a tolerable period of time and can demonstrate compliance. To address this hypothesis we created these aims: 1. Construction and optimization of a device utilizing light guide technology to deliver phototherapeutic light to the entire oral mucosa simultaneously. Manufacturing a device that meets the output and safety requirements detailed in this proposal will complete this aim. 2. Demonstration of patient compliance and safety in a controlled clinical environment. A pilot study will be comprised of head and neck cancer patients undergoing radiation while receiving phototherapeutic treatment under conditions mimicking expected end use. The device will be evaluated based on fitness for intended use and patient safety. Upon completion of Phase I, we will successfully have developed a phototherapeutic mouthpiece capable of delivering the required light dosage in an effective, controlled manner. During Phase II we will develop a manufacturable, sterilizable, cost-effective iteration for commercialization and prove its clinical efficacy. Our long-term goal is to create a home-based device for all patients at risk for developing Oral Mucositis, allowing the clinician to control dosage and the patient to self- administer.

Public Health Relevance Statement:


Public Health Relevance:
In this Phase I SBIR, Lumitex plans to develop an intraoral phototherapeutic device for the treatment and prevention of Oral Mucositis. Oral Mucositis is one of the most severe and debilitating side-effects of Chemo- and Radio-therapy affecting more than 450,000 people annually and can lead to $40,000 in additional hospital charges per patient. Patients are often unable to eat, sleep or speak which leads to depression and social isolation. We expect our non-invasive device can provide a safe, effective and tolerable treatment to eliminate this serious side-effect.

Project Terms:
Acceleration; Address; Adoption; Adverse effects; Affect; base; Biocompatible; cancer therapy; Cell Death; Cells; Charge; chemoradiation; Clinical; Clinical Data; clinical efficacy; commercial application; commercialization; Compliance behavior; Consultations; cost; cost effective; Custom; Devices; Diagnosis; dosage; Dose; Eating; Engineering; Environment; Equipment; fitness; flexibility; Goals; head and neck cancer patient; Health Care Costs; Home environment; Hospital Charges; Infection; Inflammation; innovation; irradiation; Lasers; Lead; Letters; Light; Low-Level Laser Therapy; Malignant Neoplasms; Manufacturer Name; Marketing; Medical Device; Medical Electronics; meetings; Mental Depression; Methods; Mortality Vital Statistics; Mucositis; Mucous Membrane; novel; Oral; Oral cavity; oral mucositis; Oral mucous membrane structure; Outcome; Output; Pain; palliative; patient safety; Patients; Penetration; Pharmacologic Substance; Phase; Phototherapy; Pilot Projects; prevent; Prevention; Production; public health relevance; Radiation; Radiation therapy; Reporting; Risk; Safety; Self-Administered; Silicones; Sleep; Small Business Innovation Research Grant; Social isolation; Spottings; standard of care; Supervision; Supportive care; Technology; Testing; Therapeutic; Thick; Time; Tissues; Tonsil; Toxic effect; treatment duration; United States; Variant

Phase II

Contract Number: 2R44DE026082-02A1
Start Date: 4/1/2016    Completed: 8/31/2020
Phase II year
2018
(last award dollars: 2019)
Phase II Amount
$1,488,768

The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral Mucositis (OM). OM is one of the most common and highly significant toxicities of cancer therapy. Approximately 375,000 patients are affected by OM in the United States each year. OM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaks, increased 100-day mortality and a considerable increase in healthcare costs. The standard of care for patients with OM is mainly palliative, aiming to reduce pain, inflammation, and risk of infection. A new and proven approach for treatment and prevention of OM is Photobiomodulation (PBM) Therapy. Specific dosages of red light demonstrate increased production of ATP which protects the mucosa from cell death. Current barriers to the use of PBM Therapy include the cost of laser equipment, labor intensiveness, inter-operator variability, and lack of dose control. As the result of the successful completion of the Phase I grant, Lumitex developed the OralGlo?, a flexible, biocompatible silicone light guide to irradiate OM-susceptible regions of the oral mucosa with therapeutic light. The key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfort. Our light delivery technology can be integrated into a mouthpiece that safely delivers 2-10 J/cm2 of light directly to the oral mucosa in under ten minutes. To complete the preclinical validation of the OraGlo, we created these aims: Aim 1: Incorporate design refinements and validate performance. Completion of this aim will result in 32 devices that have +/-20% uniformity to all targeted delivery zones and certification to applicable safety standards. Aim 2: Perform a dose- escalation study in vitro to determine the optimal therapeutic dosage range. Successful completion of this aim will result in the determination for the maximum dosage before cell death occurs and determine the dosage for peak cellular response. Aim 3: Confirm no tumor progression due to LED PBM therapy in a mouse model. A study of mice implanted with squamous cell carcinomas and undergoing PBM therapy will be conducted. Completion of this aim will result in no statistically significant increase in tumor growth rate associated with our device compared to control. Upon completion of Phase II, we will successfully have refined and validated a phototherapeutic mouthpiece capable of delivering the therapeutic light dosage in an effective, controlled manner. Next steps will be to conduct clinical studies using the OraGlo in Head and Neck cancer patients. The long term goal for the product is to shift the paradigm for OM management from palliative, to treatment and prevention. This technology would be the first PBM product approached for treatment, enabling many new light-based wound healing applications.

Thesaurus Terms:
Address; Adenosine Triphosphate; Adoption; Adverse Effects; Affect; Air; Anti-Cancer; Anticancer Treatment; Base; Biological Assay; Biomaterial Compatibility; Cancer Patient; Cancer Therapy; Cell Death; Cell Motility; Cell Survival; Certification; Charge; Chemoradiation; Chemotherapy; Clinical; Clinical Research; Commercial Application; Cost; Custom; Data; Design; Devices; Dosage; Dose; Eating; Engineering; Equipment; Experience; Fiber Optics; Flexibility; Foundations; Funding; Future; Goals; Grant; Head And Neck Cancer; Head And Neck Cancer Patient; Health Care Costs; Hematopoietic Stem Cell Transplantation; Hospitalization; Implant; In Vitro; In Vivo Imaging; Incidence; Infection; Inflammation; Innovation; Investments; Irradiation; Keratinocyte; Lasers; Legal Patent; Light; Manufacturer Name; Marketing; Mechanics; Mediating; Medical; Medical Device; Meetings; Methods; Modality; Modeling; Mortality; Mouse Model; Mucous Membrane; Multiple Trauma; Mus; Novel; Novel Therapeutics; Nude Mice; Optics; Oral; Oral Cavity; Oral Mucositis; Oral Mucous Membrane Structure; Outcome; Pain; Pain Reduction; Palliative; Pathway Interactions; Patient Care; Patients; Performance; Pharmaceutical Preparations; Phase; Phase 1 Study; Phase 2 Study; Photobiomodulation; Phototherapy; Pre-Clinical; Preclinical Evaluation; Preclinical Testing; Prevent; Prevention; Production; Quality Of Life; Radiation; Residual Cancers; Response; Risk; Safety; Saliva; Silicones; Sleep; Small Business Innovation Research Grant; Squamous Cell Carcinoma; Standard Of Care; Supervision; Surgical Instruments; System; Targeted Delivery; Technology; Tgfb1 Gene; Therapeutic; Therapeutic Effect; Time; Tissues; Tongue; Tonsil; Toxic Effect; Transplant Recipients; Treatment Center; Tumor Growth; Tumor Progression; United States; Validation; Wound Healing;