Anderson D W
MicroMed Technology, Inc., Houston, Texas 77054, USA.
Artif Organs. 2001 May;25(5):406-10. doi: 10.1046/j.1525-1594.2001.025005406.x.
The heart failure industry or sector of blood pump technologies comprised of scientists, medicine, and business has inadequate attention from the financial community due to the perception of unmet market potential and regulatory hurdles. There are more than 20 mechanical circulatory support technologies currently in some stage of development. The application is defined initially for emerging technologies as bridge-to-transplant whereas more mature devices have focused on bridge-to-recovery and alternative-to-transplant. Regulatory hurdles and financing resources have dictated this initial application strategy. Whether a technology has valves, bearings, is magnetically suspended, acts as a pressure cuff, and so on, the future will belong in large part to those technologies that are less expensive, have improved ergonomics, are simpler in surgical application, and can demonstrate efficacy levels that are an improvement over today's approved devices. Today's devices have provided a valuable platform for the emerging technologies. However, there has been little market expansion over these past years, relative to the potential market. The cardiologist is the patient's gatekeeper, and drugs appear to be the therapy of choice as options are considered. Technologies without a business model will have a difficult time attracting much needed funding, the result being protracted development times or project termination. MicroMed has modified its ventricular assist device (VAD) focus, with a broader look at treating the heart failure patient. MicroMed recently entered into an agreement with Chrysalis Biotechnology, Inc., Galveston, TX, covering a synthetic peptide technology (Chrysalin) that when injected into tissue has demonstrated an angiogenic effect without the concerns inherent in recombinant angiogenic/growth factors. We believe a combination therapy of the DeBakey VAD-synthetic peptide could provide sufficient revascularization for bridge-to-recovery or as an alternative-to-transplant in certain patients.
由科学家、医学专家和商业人士组成的心力衰竭产业或血泵技术领域，由于市场潜力未得到满足以及监管障碍等因素，未得到金融界的充分关注。目前有20多种机械循环支持技术正处于不同的开发阶段。新兴技术最初的应用定义为桥接移植，而更成熟的设备则专注于桥接恢复和替代移植。监管障碍和融资资源决定了这一初始应用策略。无论一种技术是否有瓣膜、轴承、是否采用磁悬浮、是否用作压力袖带等等，未来在很大程度上都将属于那些成本更低、人体工程学设计更好、手术应用更简单且能证明其疗效比现有获批设备有所提高的技术。当今的设备为新兴技术提供了一个有价值的平台。然而，相对于潜在市场而言，在过去几年里市场扩张甚微。心脏病专家是患者治疗的把关人，在考虑各种治疗选择时，药物似乎是首选治疗方法。没有商业模式的技术很难吸引到所需的资金，结果是开发时间延长或项目终止。MicroMed已经调整了其心室辅助装置（VAD）的重点，更广泛地关注心力衰竭患者的治疗。MicroMed最近与德克萨斯州加尔维斯顿的Chrysalis生物技术公司达成了一项协议，涉及一种合成肽技术（Chrysalin），该技术注入组织后已显示出血管生成作用，且不存在重组血管生成/生长因子固有的问题。我们相信，DeBakey VAD与合成肽的联合疗法可以为某些患者提供足够的血管再生，用于桥接恢复或作为替代移植的方法。
