Biocompatibles’ BrachySciences Division, offers new alternatives for Low Dose Rate Brachytherapy with innovative custom kits for both Real-Time and Pre-Planned implants. BrachySciences has been responsible for the development of innovative brachytherapy products to facilitate more precise implants thereby leading to better patient outcomes and lower morbidity.

Pre-Loaded Kits provide ease and convenience for Pre-Planned Low Dose Rate Brachytherapy implants:
Low Dose Rate Brachytherapy kits are customized to each patient’s pre-plan, contain pre-loaded Seed-Lock3™ needles and are delivered sterile and ready for use, minimizing time and radiation exposure in the Operating Room. The custom kits can be pre-loaded with: VariStrand™, StandardStrand™, EchoStrand™, VariLoad™ and StandardLoad™, all designed to enhance low dose rate brachytherpay implants. Each pre-loaded kit comes with a 10% third party assay verifying source strength and a radiograph verifying needle loading patterns.

For more information, please see: http://www.brachysciences.com/UDS/ 

VariStrandTM - Variable Spacing in Strands for Low Dose Rate Brachytherapy

VariStrand™ is the flagship product in BrachySciences’ strand portfolio, consisting of low dose rate brachytherapy sources encapsulated in a synthetic bioabsorbable polymer. VariStrand™ is capable of accommodating any seed pattern: standard spacing, urethral sparing, optimized spacing, back-to-back seeds, baseline loading, or any combination thereof. 

For more information, please see: http://www.brachysciences.com/varistrand/

StandardStrandTM – Standard Spacing in Strands for Low Dose Rate Brachytherapy

StandardStrand™ is the value product in BrachySciences’ strand portfolio, consisting of low dose rate brachytherapy sources encapsulated in a synthetic bioabsorbable polymer. StandardStrand™ consists of loading patterns exhibiting 1.0 cm center-to-center spacing.

For more information, please see: http://www.brachysciences.com/strand/ 

EchoStrandTM - The next Generation Strand for Low Dose Rate Brachytherapy

EchoStrand™ is the most technologically advanced product in BrachySciences’ strand portfolio. Like VariStrand™ it can accommodate any conceivable loading pattern. However, EchoStrand™ is formed using an echogenically enhanced bioabsorbable polymer, allowing the entirety of the strand to be better visualized under ultrasound.

For more information, please see: http://www.brachysciences.com/es/ 

VariLoadTM – Variable spacing with loose seeds and spacers

VariLoad™ is the premier loose-loaded product in BrachySciences’ pre-loaded kit portfolio, consisting of loose low dose rate brachytherapy sources in combination with custom synthetic bioabsorbable spacers. The custom spacers allow for VariLoad™ to accommodate any conceivable loading pattern, including standard spacing, urethral sparing, optimized spacing, back-to-back seeds, baseline loading, or any combination thereof.

For more information, please see: http://www.brachysciences.com/variload/ 

StandardLoadTM – Standard spacing with loose seeds and spacers

StandardLoad™ is the value product in BrachySciences’ pre-loaded kit portfolio, consisting of loose low dose rate prostate brachytherapy sources in combination with 5.5 mm synthetic bioabsorbable spacers. StandardLoad™ consists of loading patterns exhibiting 1.0 centimeter center-to-center spacing.

For more information, please see: http://www.brachysciences.com/stndload/ 

Innovative Solutions create flexibility for Intra-Operative Planning of Real-Time Low Dose Rate Brachytherapy Implants.

RTSTM – Pre-Defined Strands with Real-Time Capabilities

RTS™ Real-Time Strands. Each strand consists of ten low dose rate brachytherapy sources spaced out at one centimeter center-to-center. Strands are made from a synthetic bioabsorbable polymer and are designed to be cut and loaded in the operating room. Strands are delivered sterile and shielded in a special cutting board carrier. Extra spacing lengths are provided as part of the kit for the intra-operative construction of special loads. Each RTSTM kit comes with your choice of Seed-Lock3TM or “Applicator” style needles in separate, sterile pouches and each kit comes with a 10% third party assay verifying source strength.

For more information, please see: http://www.brachysciences.com/rts/ 

CRTSTM – Variable Spacing, Reduced Preparation Time with Real-Time Capabilities

CRTS™ - Custom Real-Time Strands. Strands designed for intra-operative loading, consisting of low dose rate prostate brachytherapy sources encapsulated in a synthetic bioabsorbable polymer. Strands can be from 1.5 to 6.0 centimeters in length and can exhibit standard spacing, urethral sparing, optimized spacing, back-to-back seeds, baseline loading, or any combination thereof. The strands are provided in a special carrier, shielded and sterile. CRTSTM allows for easy loading of strands in the OR. Each CRTSTM  kit comes with your choice of Seed-Lock3TM or “Applicator” style needles in separate, sterile pouches. Each case comes with a 10% third party assay verifying source strength and a radiograph verifying strand patterns.

For more information, please see: http://www.brachysciences.com/crts/

AnchorSeed™ -  Flexibility of a Mick® Implant with the “fixity” of a strand

AnchorSeed™ is uniquely designed to give existing low dose rate brachytherapy sources (iodine-125) enhanced ability to maintain their position within prostate cancer tissue, thereby allowing physicians to confidently place seeds in more strategic and beneficial locations.

AnchorSeed™ has been designed to improve loose seed fixity and reduce:
* Misalignment
* Migration
* Vacuum Phenomena

The "anchor effect" provides added confidence in placing seeds:
* Closer to the periphery
* Within the peri-urethral areas
* Closer to the apex and base

For more information, please see: http://www.anchorseed.com/ 

Mick® is a registered trademark of Mick Radio-Nuclear Instruments, Inc.

Clinical trials/clinical strategy
Implants have been performed throughout the United States, and physicians are collecting data with the intent to publish the results of their AnchorSeed experience.

SeedLock3TM Needle – The most widely used pre-plugged needle for Low Dose Rate Brachytherapy

Seed-Lock3TM  needles contain a synthetic plug 1.5mm in length which is consistent in size and position, allowing for confident location of the first seed in every needle. The exclusive ESD (electro-static dissipating) clear hub material actively removes static from the seeds and spacers. The vented stylet eliminates unwanted seed displacement from vacuum phenomena.

For more information, please see: http://www.brachysciences.com/seedlock/ 

Clinical Trials / Clinical Strategy
Strands have a long clinical history of providing superior dosimetric outcomes and significantly reduced seed migration.

Lee, WR et. al. “Radioactive sources embedded in suture are associated with improved postimplant dosimetry in men treated with prostate brachytherapy” Radiotherapy and Oncology 2002 Nov;65(2):123-7.

Fuller, DB et. al. “Prostate brachytherapy seed migration and dosimetry: analysis of stranded sources and other potential predictive factors” Brachytherapy. 2004;3(1):10-9.

Lin, K et. al. “Improvements in prostate brachytherapy dosimetry due to seed stranding” Brachytherapy. 2007 Jan-Mar;6(1):44-8.

Tapen, EM et. al. “Reduction of radioactive seed embolization to the lung following prostate brachytherapy” International Journal of Radiation Oncology Biology Physics. 1998 Dec 1;42(5):1063-7.

Merrick GS et. al. “Seed fixity in the prostate/periprostatic region following brachytherapy” International Journal of Radiation Oncology Biology Physics. 2000 Jan 1;46(1):215-20.

Customized monofilament: a new approach to permanent prostate brachytherapy – M. Bouffard.

IP Rights:
Covered under US Patent No., 6,554,760 - 6,761,680 - 6,786,858 - 6,820,318 
Other US and International Patents Pending

Market Overview:
According to the American Cancer Society, nearly 219,000 new cases of prostate cancer were projected to be diagnosed in 2007, making it the most commonly diagnosed cancer in American males . It trails only lung cancer as the leading cause of cancer deaths amongst American males, with a projected mortality total of more than 27,000 in 2007 .

There are a wide variety of treatment options for prostate cancer, ranging from fully invasive (radical prostatectomy) to entirely non-invasive (watchful waiting or active surveillance). The minimally invasive option of low dose rate (LDR) brachytherapy has proven clinically to be a very effective treatment for the prostate cancer patient presenting the proper indicators (locally confined, stage T1-T2b, PSA<10ng/ml, Gleason 2-6, gland < 60 cc) , . LDR brachytherapy accounts for the treatment of approximately 60,000 prostate cancer patients per year .

References
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iAmerican Cancer Society, Cancer Facts & Figures 2007, http://www.cancer.org,
ii Ibid.
iii Ragde, H. et al. “Ten-year disease free survival after transperineal sonography-guided iodine-125 brachytherapy with or without 45-gray external beam irradiation in the treatment of patients with clinically localized, low to high Gleason grade prostate carcinoma.” Cancer. 1998 Sep 1;83(5):989-1001.
iv Data on file.
v Data on file.
vi Data on file.