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这些独特的技术产品,

即拥有完整的知识产权保护,又有生产厂家的支持服务。我们为您提供中英文版本的介绍草案,中文部分请向下拖拉。


Technology licensing and IP rights Transfer Offer

The offer of these exclusive technology products featuring complete I.P. protection and producer support, are offered in English and Chinese. For Chinese please scroll down the page.


组织再生和创伤溃疡

美国设计与工艺专利,已通过美国食品和药物管理局第一和第二阶段临床试验,第三阶段正在完成最后20项临床试验

tissue1


产品

在美国和欧共体中,组织再生品已是一个快速成长的市场。随着糖尿病相关性溃疡创面和创伤的增加,从烧伤创面、事故、疾病和相关领域,该产品是现代医疗保健补救措施中的一个重要组成部分。该产品是生物成分结合了敷料功能。公司首选治疗糖尿病脚溃疡向官方提交生产许可。同样的产品配置,适用于许多其他领域,如伤口静脉瘀血性溃疡,压力性溃疡。


市场

糖尿病影响全球超过200,000万人,到2030年,这个数字有可能增加一倍。那些糖尿病的影响的, 25%在他们的一生将患脚溃疡。相比较而言,本公司相信我们的产品将有效治愈更多的糖尿病足溃疡、口静脉瘀血性溃疡和压力性溃疡。该产品是通过生物生长因子和细胞因子的结合,来帮助伤口组织修复的过程,刺激愈合。


Skin Ulcers

by Type


U.S. Yearly Incidence


Global Yearly Incidence

Diabetic Foot Ulcers


2.3 million


20.0 million

Venous Ulcers


1.2 million


8.0 million

Pressure Ulcers


2.5 million


9.0 million

Total


6.0 million


37.0 million

易用性

不论是实习护士,亦或医生,可以迅速应用本产品。它不需要外科医生将其缝合在皮肤上或做任何其他复杂的准备。应用过程中,只需将产品直接敷在伤口并将贴上敷料以保护伤口。与其他高端生物产品比较,整个临床治疗只需要10 - 15分钟。


有效的伤口愈合

只有20%的溃疡患者,在常规护理治疗的12个星期内愈合。来自于关键试验多样中心的内部分析,初步结果显示,在当今市场,使用本产品的患者,其平均治愈时间,要比同类高端或常见产品来得早很多。 tissue2 Week 1 tissue3 Week 2 tissue4 Week 3 tissue5 Week 4


产品的关键指标:


使用

烧伤领域

+ 皮肤移植供体网站

+ 偏度烧伤创面

+ 深Ⅱ度烧伤创面

+ 肥厚性疤痕

     + 其他皮肤疾病,如表皮Bulosa


手术创面

+ 去除(一直到真皮深层的文身)

+ 截肢残端

+ 创伤伤口(军事)

+ 疤痕的修复

+ 瘢痕疙瘩去除


高效临床结果

+ 与现有产品相比,具更高的疗效和更短的治愈时间

+ 减少感染风险

+ 愈合后的溃疡,复发率为零

+ 无论是急性或慢性病患者,不存在不适或减少不适

+ 在现有产品中具最佳的安全外形

+ 疗效迅速、更快的结束疗程,病患可以很快出院回家

+ 能处理更广泛的患者群(及最具挑战性的病人治疗组)


提升黄金标准

+ 普通常见和使用方法和流程,医生通过极简单的培训即可使用

+ 让患者可以尽早工作,增加了产品的可流动性和提高产量,同时降低医疗保健制度成本

+ 消除了大部分住院的需要


知识产权

+ 六项专利技术,由密歇根大学和韦恩州立大学的校董会签发给本公司独家应用

+ 此外,一项最新独立发现再生医学的专利应用,直接本公司所有


监管机构的批准

      +美国食品和药物管理局(“美国FDA”)将本产品归为第三类医疗器械产品

+ 2005年,本公司完成了该产品的最初试验及安全研究,并将数据提交给美国FDA

+ 美国FDA批准向关键试验多样中心扩展研究

+ 本公司为24个机构招聘主要研究者参与230个项目试验的注册。目前已有186项目注册成功,公司预计将在2011年下半年完成全部项目的注册工作。

+ 本公司已向FDA提交了一部分糖尿病足溃疡由本产品治疗后的PMA应用,迄今,已收到可贵的反馈。公司将在2012年的早些时候,提交最后一部分的市场适用报告,并在2012年第三季度,提交预测的工商业效用。


实用性:

+领先的专利医疗设备的直接投资机会

+即刻获取技术的权利

+合作生产权


如您对上述任何一个方案感兴趣,请按以下方式联系我们:

尖峰技术股份有限公司

沃尔那特北大街520号

印弟安那州布卢明顿市

邮编:47404


请洽:谢凯文 先生 / Kevin Jeffers

中国资产管理部 副总裁

电话:(812) 606-1550

传真:(812) 335-1961

信箱地址:

印弟安那州布卢明顿市

1772信箱

邮编:47402



Tissue regeneration from ulcers and wounds


tissue1

U.S. Design and Process Patented, USA Food and Drug Administration Phase I and II, Phase III pending final 20 clinical trials


Technology licensing and IP rights Transfer Offer

The offer of these exclusive technology products featuring complete I.P. protection and producer support, are offered in English and Chinese. For Chinese please scroll down the page.


The Product

Tissue regeneration product is a fast growing market segment in the USA and EU. With the increase in diabetic related ulcer wounds, and wounds from burns, accidents, diseases and conflict zones, the Product is an important part of modern healthcare remedies. The Product combines a dressing function with a biological component. The Company has selected diabetic foot ulcers as the first indication in its regulatory path. The same product configuration is applicable to many other wound areas such as venous stasis ulcers and pressure ulcers.


The Market

Diabetes affects over 200,000 million people worldwide, a number which is likely to double by 2030. Of those affected by diabetes, up to 25% will develop a foot ulcer in their lifetime. The Company believes that Product will heal more diabetic foot, venous stasis and pressure ulcers than any other product. The Product stimulates healing by providing a combination of biological growth factors and cytokines to assist the wound tissue with the repair process.

Skin Ulcers

by Type


U.S. Yearly Incidence


Global Yearly Incidence

Diabetic Foot Ulcers


2.3 million


20.0 million

Venous Ulcers


1.2 million


8.0 million

Pressure Ulcers


2.5 million


9.0 million

Total


6.0 million


37.0 million

Ease of Use

The Product can be applied quickly by a nurse practitioner or a doctor and does not require a surgeon to suture the product to the skin or any other complex product preparation. The application process involves placement of the Product directly on the wound and placement of an outer dressing to protect the wound. The entire clinical procedure requires only 10 – 15 minutes in comparison to competitive biologics.


tissue2 Week 1 tissue3 Week 2 tissue4 Week 3 tissue5 Week 4


Effective Wound Closure

Only an estimated 20% of ulcers treated with conventional care heal within 12 weeks. Preliminary results from the internal analysis of the Multicenter Pivotal Trial showed that the average time to healing for patients treated with Product was much earlier than either advanced or other active products on the

market today.


Brief key product points:


Use

Indications for Use


   *
     Indicated for patients with Type 1 or Type 2 diabetes mellitus with an ulcer on the plantar surface of the forefoot or heel.
   *
     For use with standard diabetic foot ulcer care for treatment of neuropathic diabetic foot ulcers that extend into the dermis but without tendon, muscle, joint capsule, or bone exposure.

Burn Market

+ Skin Graft Donor Sites

+ Partial Thickness Burn Wounds

+ Deep Second Degree Burn Wounds

+ Hypertropic Scarring

+ Other Skin Disorders such as Epidermal Bulosa


Surgical Wounds

+ Removal of Tattoos (down to deep dermis)

+ Amputation Stump

+ Trauma Wounds (Military)

+ Scar Revisions

+ Keloid Removal


Cosmetic Applications

+ Surgical Procedure

+ Lacerations

+ Laser Procedures


Superior Clinical Results

+ Higher efficacy and time to healing than existing products

+ Reduction in the risk of infection

+ No recurrence rate of healed ulcer

+ Absence or reduction of patient discomfort: either acute or chronic

+ Best safety profile among existing products

+ Faster application, faster completion of procedure releasing patient quickly

+ Able to treat a wider patient population (most challenging patient treatment groups)


Enhancement to the Gold Standard

+ Minimal physician training required – common practice and procedure

+ Allows for earlier time to back to work, increased mobility and throughput and, and lower costs to the health care system.

+ Eliminates the need for most hospitalizations.


Intellectual Property

+ Six patents covering the technology have been issued and exclusively licensed to the Company by the Regents of the University of Michigan and Wayne State University.

+ One additional patent application has been filed directly by the Company covering novel proprietary discoveries in regenerative medicine.


Regulatory Approval

+ The United States Food and Drug Administration (“FDA”) has classified the Product as a Class III medical device.

+ The Company completed its initial pilot safety study of the Product and presented the data to the FDA in 2005.

+ The FDA approved expansion of the study into a Multicenter Pivotal Trial in the United States.

+ The Company has recruited key investigators at 24 institutions to enroll 230 subjects for the trial. There are currently 186 subjects enrolled and the Company estimates that all required participants will be enrolled by the latter half of 2011.

+ The Company has submitted a portion of the PMA application for Product to the FDA for the treatment of diabetic foot ulcers and has received valuable feedback thus far. The Company will submit the final portion of its market application early in 2012 with commercial availability projected by the 3rd quarter of 2012


Availability:

+ Immediate investment opportunity in this leading patented medical device

+ Immediate access to technology rights

+ Co-operative production rights


If you are interested in one of these product offerings, contact us at the following address:


Pinnacle Technology LLC

520 North Walnut Street

Bloomington Indiana 47404


Attention: Kevin Jeffers

Vice President Asset Management / China

Phone number: (812) 606-1550

Fax number: (812) 335-1961


Mailing address:

P.O. Box 1772

Bloomington, In 47402

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