StrataXRT

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StrataXRT

StrataXRT – an innovative, flexible wound dressing for the prevention and treatment of radiation
dermatitis

Ingredients: Polydimethylsiloxanes, Siloxanes, Alkylmethyl Silicones

About Stratpharma

Stratpharma is an innovative topical medical devices to improve the procedures in dermatology, plastic
surgery, gynaecology, geriatrics and radiation oncology. Stratpharma is powered by collaborative R&D projects
and an ambitious pipeline in topical dermatology. We are dedicated to improve unmet needs of patients.
Developed cutting-edge solutions to improve clinical outcomes and quality of life

Radiation Dermatitis

Prolonged exposure to ionizing radiation may eventually lead to the development of radiation dermatitis (RD).
Very common side effect which occurs during ongoing radiation therapy and affects 75% – 95% of patients.
First symptoms occurs 10 – 14 days after the first radiation therapy dose

When radiotherapy continues, the body may not produce enough new cells to replace the old ones. The
severity of skin reactions may increase for 2 more weeks after the completion of radiation therapy

STRATAXRT

StrataXRT is an innovative, film-forming wound dressing. The formula of StrataXRT was specifically developed
to manage radiation dermatitis. The StrataXRT gel can be spread easily which is why only a very small amount
of product is required.

Mechanism of Action

StrataXRT helps to reduce Trans Epidermal Water Loss (TEWL) while promoting a moist wound
healing environment

StrataXRT protects the fragile epidermis during dry desquamation

Advantages of StrataXRT
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 Approved and available in EU, Australia and USA

 StrataXRT is transparent and odorless. It does not contain alcohol, fragrances or parabens.
 StrataXRT is a non-absorbable wound dressing.
 StrataXRT is suitable for all skin types.
 StrataXRT is non-reactive with no measurable pH.
 StrataXRT is convenient and easy to use at home.
 StrataXRT can be used in combination with other dressings.
 StrataXRT is sterile until opened and bacteriostatic for continuous applications
 StrataXRT Does Not Cause Bolus Effect

Dosing Schedule

Apply once daily, or twice daily to exposed areas or as advised by your doctor. For best results, StrataXRT
should maintain in continuous contact with the skin (24 hours a day/ 7 days a week). StrataXRT is
recommended to be applied following the initial radiation dose and should continue to be used for a minimum
of 60–90 days (24/7) post-radiation therapy, or until no further improvement is seen. For chronic radiation
dermatitis, continued use is recommended until no further improvement is seen

Clinical results with StrataXRT

A 28-patient multicenter study performed in Spain (2015). Starting of therapy RTOG score of 2.5 +/- 0.5.

All patients were treated with StrataXRT while undergoing radiation therapy. 13 S ces the severity of
radiation induced skin reactions and significantly decreases the RISRAS score, even if patients are undergoing
radiation therapy treatment

StrataXRT Does Not Cause Bolus Effect

The Springfeld Radiation Oncology Center in Australia conducted measurements on increasing electron beam
energy levels to verify the bolus effect of a clinical dose of StrataXRT. This study showed that StrataXRT does
not cause bolus effect since the energy of the beam is not affected by the product
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StrataXRT vs Common Treatment Regimen

Skincare Overall Costs during Radiation Therapy Treatment

How supplied?

StrataXRT 20g size contains enough gel for over 2 weeks of treatment during a standard fractionation plan*
applying the gel twice per day. StrataXRT 50g size contains enough gel for over 5 weeks of treatment during a
standard fractionation plan* applying the gel twice per day

Regulatory Status:

Registered as Medical Device

Availability and approved in

Australia, Austria,Belgium,Bulgaria,Canada,Germany, Italy, Hungary, Italy, Ireland, Slovenia, Poland, Portugal,

Czech republic, Denmark, Norway, Romania, Spain, USA, Switzerland, New Zealand , Netherlands

Target patients for Opportunity assessment:

Patients undergoing radiation for solid tumors

Key evaluation points

 Novel concept and would require some level of market creation work
 Regulatory pathway for registration
 Mostly out of pocket