Memphasys Accelerates Commercial Approval for Sperm-separation Device
Memphasys Accelerates Commercial Approval for Sperm-separation Device
Despite innovative technology, Memphasys (ASX:MEM) has been swimming against the tide in recent times. But with the company poised to bank $4.23 million in a capital raising and having signed expanded distribution agreements, wary investors can expect better times as the company shifts from a research and development focus to commercialisation.
尽管有创新技术，但Memphasys（澳大利亚证券交易所股票代码：MEM）最近一直在逆势而上。但是，随着该公司准备存入423万澳元的融资，并签署了扩大的分销协议，随着公司从研发重点转向商业化，谨慎的投资者可以预期，情况会更好。
Memphasys acting CEO Dr David Ali acknowledges the ASX-listed company needs to expedite the registration study for its flagship assisted sperm-separation system, Felix. in 2024.
孟菲斯代理首席执行官戴维·阿里博士承认，这家在澳大利亚证券交易所上市的公司需要在2024年加快其旗舰辅助精子分离系统Felix. 的注册研究。
"The company has been driven largely by R&D and it's time to flip that to commercialisation. Whilst we have an unparalleled innovation hub, we will be seeking to build on commercial planning. We will adopt a view of innovative transformative research with a clear path to commercial outcomes," he says.
“该公司主要由研发驱动，现在是时候将其转向商业化了。尽管我们拥有无与伦比的创新中心，但我们将寻求在商业规划的基础上再接再厉。我们将采用创新的变革性研究观点，为取得商业成果铺平道路，” 他说。
The company has launched a much-needed capital raising, by way of a $2.1 million placement and a $2.13 million underwritten rights issue. The offer closed on January 9.
该公司通过210万澳元的配售和213万美元的承保供股发行，启动了急需的融资。该优惠已于1月9日结束。
The funds will expedite the previously lagging Felix registration study and facilitate regulatory approval from the local Therapeutic Goods Administration (TGA).
这些资金将加快此前滞后的费利克斯注册研究，并促进当地治疗用品管理局（TGA）的监管批准。
The remainder of the funds will support other device development in the human and animal health sectors (see below).
其余资金将支持人类和动物健康领域的其他设备开发（见下文）。
The company's business development manager since March this year, Dr David Ali took the helm in late November after CEO Alison Coutts stepped down after a decade in the job.
首席执行官艾莉森·库茨在任职十年后辞职后，戴维·阿里博士自今年3月起担任该公司的业务发展经理，于11月下旬掌舵。
Ali has wide experience in drug commercialisation and discovery, transformational and clinical research and medical affairs, including a decade as a researcher at the CSIRO.
阿里在药物商业化和发现、转型和临床研究以及医学事务方面拥有丰富的经验，包括在CSIRO担任研究员的十年。
Ali says he was lured to the company because its products were "streets ahead" of any rival.
阿里说，他之所以被吸引到该公司，是因为该公司的产品 “比任何竞争对手都要好得多”。
"The Felix system is capable of being truly disruptive globally for the growing IVF market," he says. "It has had delays but is now on a clear path to achieving commercialisation success."
他说：“对于不断增长的试管婴儿市场，Felix系统能够在全球范围内产生真正的颠覆性。”“它遇到了延误，但现在已经走上了实现商业化成功的明确道路。”
Coutts remains the company's third-biggest shareholder and will continue to provide external consulting advice.
库茨仍然是该公司的第三大股东，并将继续提供外部咨询建议。
The company's second-biggest investor, Andrew Goodall also retired from the board after a 13-year stint. Both Coutts and Goodall subscribed to the rights issue, alongside converting debt – provided as working capital - to equity.
该公司的第二大投资者安德鲁·古道尔在任职13年后也从董事会退休。库茨和古道尔都认购了配股，同时将作为营运资金提供的债务转换为股权。
Alongside Goodall, Coutts rescued the troubled company, then known as Nusep. Crucially, she established relationships with the University of Newcastle's Professor John Aitken, a global fertility expert and now the company's research director.
库茨与古道尔一起拯救了这家陷入困境的公司，当时名为努塞普。至关重要的是，她与纽卡斯尔大学的约翰·艾特肯教授建立了关系。约翰·艾特肯教授是全球生育专家，现任该公司的研究主任。
Aitken has been a crucial force in developing Felix, which separates sperm efficiently for in-vitro fertilisation (IVF) purposes. The process, electrophoresis – separates molecules using electrical charge.
艾特肯一直是开发Felix的关键力量，Felix可以有效地分离精子，用于体外受精（IVF）的目的。这个过程，即电泳，使用电荷分离分子。
The most common sperm-separation technique - density gradient centrifugation (DGC) - risks accentuating cell damage because of the powerful forces involved.
最常见的精子分离技术——密度梯度离心（DGC）——由于涉及强大的力量，有加剧细胞损伤的风险。
Another method, 'swim-up' - is also not ideal. As its name suggests, the 'tadpoles' that survive the arduous journey up the fallopian tubes are deemed the fittest, but they may still be damaged.
另一种方法，“游泳”-也不理想。顾名思义，在艰苦的输卵管旅程中幸存下来的 “蝌蚪” 被认为是最适合的，但它们仍可能受到损坏。
The gentler Felix process also takes about six minutes, compared with 30-45 minutes for the conventional methods.
较温和的费利克斯过程也需要大约六分钟，而传统方法则需要30-45分钟。
Given high IVF failure rates, selecting the best-of-the-best sperm is imperative. With a global decline in male sperm counts, choosing the best 'swimmers' is even more important.
鉴于试管婴儿失败率很高，选择最好的精子势在必行。随着全球男性精子数量的下降，选择最好的 “游泳运动员” 显得更加重要。
In 2018, Memphasys struck a collaboration with the ASX-listed Monash IVF, centered on a trial comparing Felix with DGC or 'swim-up'.
2018年，Memphasys与在澳大利亚证券交易所上市的莫纳什试管婴儿进行了合作，重点是将Felix与DGC或 “swim-up” 进行比较的试验。
The trial results will support the company's TGA application, expected to be lodged in 2025.
试验结果将支持该公司的TGA申请，该申请预计将于2025年提交。
"My priority is to expedite and complete the Felix study, so we can go into registration," Ali says.
阿里说：“我的首要任务是加快并完成费利克斯的研究，这样我们就可以开始注册了。”
While TGA approval would immediately open the local market, it would also allow the company to open other markets – mainly in Asia – which accept the agency's imprimatur.
尽管TGA的批准将立即开放当地市场，但它也将允许该公司开放其他接受该机构批准的市场，主要是亚洲市场。
In India, the company racked up strong initial sales – at least until the country's regulator tightened regulation of the IVF industry.
在印度，该公司实现了强劲的初始销售额——至少在该国监管机构收紧对试管婴儿行业的监管之前是如此。
While Indian sales are suspended, a recent publication reported that Felix had resulted in 14 clinical pregnancies and eleven live births. The parents were otherwise unlikely to conceive.
尽管印度暂停销售，但最近的一份出版物报道说，费利克斯已导致14例临床妊娠和11例活产。否则父母不太可能受孕。
On January 2 the company said it had signed an exclusive distribution agreement with the Nasdaq-listed health device giant Vitrolife, covering Canada and New Zealand.
1月2日，该公司表示已与纳斯达克上市的健康设备巨头Vitrolife签署了独家分销协议，涵盖加拿大和新西兰。
The deal follows a similar compact with Vitrolife Japan, signed in August last year.
该协议是在去年8月与日本Vitrolife签署的类似协议之后达成的。
In Japan, Vitrolife has placed orders for 300 Felix cartridges to supply high-volume clinics, who are impressed by the speed of the device.
在日本，Vitrolife已订购了300个Felix墨盒，为大批量诊所供应，该设备的速度给他们留下了深刻的印象。
The company estimates the Canadian market at around 21,000 cycles per year, implying an addressable market of $2 million. The Kiwi market is about half this size. First orders from both geographies are expected in the current half.
该公司估计，加拿大市场每年约为21,000个周期，这意味着潜在市场为200万美元。新西兰的市场大约是这个规模的一半。预计这两个地区的第一批订单将在本半年出现。
Vitrolife Group (Vitrolife AB) is a publicly listed company on the NASDAQ Stockholm exchange. Crucially for Memphasys, it is a world-leading global provider of medical devices, consumables and genetic testing services dedicated to the human IVF and reproductive health market. Founded in 1994, the company employs 1,100 people across 33 countries and its products and services are available in more than 125 countries. It has manufacturing sites in Sweden, Denmark and the USA and a direct presence in 25 countries.
Vitrolife集团（Vitrolife AB）是一家在纳斯达克斯德哥尔摩交易所上市的公司。对于Memphasys来说，至关重要的是，它是全球领先的医疗器械、耗材和基因检测服务提供商，致力于人类试管婴儿和生殖健康市场。该公司成立于1994年，在33个国家拥有1,100名员工，其产品和服务遍及超过125个国家。它在瑞典、丹麦和美国设有制造基地，并在25个国家直接开展业务。
In Canada and New Zealand, Vitrolife are well established and has direct sales access to clinical partners. Memphasys has now executed distribution agreement with Vitrolife in Canada and New Zealand and is looking to follow the commercialisation plan.
在加拿大和新西兰，Vitrolife已经建立了良好的基础，可以直接向临床合作伙伴进行销售。Memphasys现已与加拿大和新西兰的Vitrolife签署了分销协议，并希望遵循商业化计划。
While Felix remains management's key focus, the company's most advanced product under development is the RoXsta device, as in Rapid In Vitro Antioxidant Assessment.
尽管Felix仍然是管理层的重点，但该公司正在开发的最先进的产品是RoxSta设备，就像快速体外抗氧化评估一样。
Formerly called Rosa, RoXsta assesses oxidative stress in semen or blood. Oxidative stress is an underlying factor in conditions including Alzheimer's diseases, diabetes, heart disease and pre-term births. This test is set to address many market gaps across multiple areas.
RoxSta 以前被称为 Rosa，用于评估精液或血液中的氧化应激。氧化应激是阿尔茨海默病、糖尿病、心脏病和早产等疾病的潜在因素。该测试旨在解决多个领域的许多市场差距。
On the animal health side, Memphasys continues to develop a Felix variant for animal artificial insemination. The more immediate potential lies with a device called AI Port, for storing and transporting livestock semen at ambient temperature – rather than harmful freezing - for a number of days.
在动物健康方面，Memphasys继续开发用于动物人工授精的Felix变体。更直接的潜力在于一种名为AI Port的设备，该设备可以在环境温度下储存和运输牲畜精液数天，而不是有害的冷冻。
The company's animal strategy is being watched no more keenly than the company's biggest shareholder, Perth horse-breeder Bob Peters.
该公司的动物战略受到关注的莫过于该公司的最大股东珀斯育马家鲍勃·彼得斯。
As part of the capital raise, Peters' Peters Investments agreed to extend the maturity date on $3 million of convertible notes, initially to February 2024 and then to December 2024.
作为筹资的一部分，彼得斯的彼得斯投资同意将300万美元可转换票据的到期日延长，最初延长至2024年2月，然后延长至2024年12月。
The latter is contingent on a shareholder vote to enable Peters to increase his voting power from a starting point above 20 per cent.
后者取决于股东的投票，以使彼得斯能够从超过20％的起点提高其投票权。
Memphasys has a lot on its plate – and in its test tubes. Fertile markets beckon, with the global opportunity for Felix alone estimated at $2 billion.
Memphasys有许多事情要做，而且在试管里也有很多。肥沃的市场在召唤，仅费利克斯的全球机会估计就达20亿美元。
"My role is to instill a calculated approach to product development and commercialisation, so that patient shareholders get a return on their investment," Ali says.
阿里说：“我的职责是灌输精心策划的产品开发和商业化方法，以便耐心的股东获得投资回报。”
