Step USA

What has to be considered if you want to start as a German biotech company on the American market? What are the legal bases and challenges there? We got an insight at the “Step USA Virtual” from June 28th until July 1st, 2021.

The four-day startup boot camp took place in New York and, due to Corona, virtually for us. Step USA was launched in 2014 by the German American Chamber of Commerce New York (GACC NY) and is organised together with the Frankfurt Main Chamber of Industry and Commerce, the TechQuartier, the Hessian Ministry of Economics, Energy, Transport and Housing, the Start Hub Hessen, the Stiftung für Technologie, Innovation und Forschung Thüringen (STIFT) and the holding company of Thuringia, bm|t. Around 40 German companies from various sectors took part, 12 of them from Thuringia. In addition to Dynamic42 GmbH, c-LEcta GmbH and others, we were among the companies selected from the bm|t portfolio.

Business culture, legal situation, immigration: How does it work in the USA?

As part of this intensive program, we got to know numerous American industry experts, mentors and investors. They advised us on US business culture, corporate marketing, raising capital, and immigration policies. The legal and tax issues were particularly interesting for us, because they form the basis for our planned market entry.

In addition to theoretical workshops, we were trained in storytelling. The business language in Germany sometimes differs greatly from the American one. Considering investor pitches in particular, it is important to know how to communicate business models convincingly in the respective culture.

A special highlight was the session with Susan Lindner on the subject of “Powerful Messaging & Storytelling”. Susan explained in an interactive way that representation plays an important role in sales. Above all, the advantages for the buyer should be emphasised more than the advantages of one’s own product.

Our personal conclusion

The four days were very informative and we learned a lot about the American corporate culture, especially for our industry! We would like to thank Andrea Diewald and Irene Fuchs from the German-American Chamber of Commerce for organising this great program.

Nevertheless, of course, a digital trip does not replace the on-site event: In autumn, the Step USA program will take place in New York again – we hope we then can be there in reality.

 

Since the beginning of 2020, when early cervical cancer screening in Germany was supplemented by a routine HPV test for women over 35, more people have been confronted with a positive test result. First, it is important to mention: This is not a reason to panic. A positive HPV test result is not to be equated with a precancerous stage or even cancer. Rather, most sexually active people become infected with human papillomavirus (HPV) at least once in a lifetime. In 90 percent of all cases, the infections heal on their own. If an HPV test is positive, this does not directly require a complex treatment. At first, only the control rhythm changes: Instead of three years, another HPV smear is carried out after twelve months. The first thing to do is to keep calm. (We’ll discuss how to get certainty quickly at the end of the blog post).

What does HPV positive mean?

A positive HPV test indicates a clinically relevant HPV infection on the cervix. This is associated with an increased risk of developing a tissue modification. These changes develop very slowly and over the years. A one-time positive HPV test therefore says nothing about cancer – it only detects a virus infection1.

If a renewed HPV smear is also positive after one year, a so-called colposcopy follows within three months. A special magnifying glass is used to clarify whether there are any changes in the tissue2.

In around ten percent of those infected, the body cannot successfully fight HPV on its own. Accordingly, tissue changes may develop that correspond to precursors of cervical cancer or may develop in the course of cancer3. In numbers, in Germany this applies to 4,500 people out of up to 500,000 who receive a conspicuous test result every year. It is therefore important to take precautions.

Differentiation between high and low risk HPV types

Over 200 different HPV types are now known. Cervical cancer or genital warts are caused by around 40 HPV types. They are divided into two categories4:

  • The low-risk types can cause bothersome and recurring genital warts. These can be treated well with various treatment options (e.g. ointments, icing, laser therapy).
  • If one of the high-risk types is detected, regular follow-up checks for cell changes are essential. The high-risk HPV types can lead to cancer, especially on the cervix. In addition, they are a possible trigger for head-and-neck tumors.

In general, it should be noted that an HPV infection itself cannot be treated. However, the respective effects should be kept in mind and tissue changes should be treated.

HPV: Partnership not necessarily affected

The initial diagnosis of an HPV infection as part of the new preventive care system often raises questions. Since regular tests for HPV in men are not currently planned, infections are primarily detected by cancer screening in women. It is important to know that the infection may have been present for many years or decades. No test procedure can answer the question of when an infection occurred. It also plays no role in the course of the normally harmless infection. The question of who infected whom in a partnership is also difficult to clarify. This is because the virus is widespread in the population as a whole. Accordingly, HPV might be noticed despite a firm partnership.

In new partnerships, the risk of infection can be reduced, for example, by using condoms during sexual intercourse. Another preventive measure is to be vaccinated against various cancer-causing HPV types5.

Quick certainty through GynTect

Of course, the waiting time between the check-ups can be stressful. A study co-authored by our managing directors Dr. Alfred Hansel and Dr. Martina Schmitz showed that the psychological stress involved in cervical cancer screening can even lead to signs of post-traumatic stress disorder6.

In order to resolve these unclear situations as quickly as possible, we have developed GynTect. The molecular biological cervical cancer test is able to detect cancer in its preliminary stages. A smear at the gynecologist is sufficient for the test.

 

[1] Projektgruppe ZERVITA (Hrsg.): HPV-Test.

[2] Deutsches Krebsforschungszentrum (DKFZ) (2021): HPV-positiv: Was nun?

[3] bis [5] Dr. med. Katharina Anstett (2020): HPV-Nachweis (Positive Testung auf ein Humanes Papillomavirus).

[6] Jentschke, M., Lehmann, R., Drews, N., Hansel, A., Schmitz, M., Hillemanns, P. (2020): Psychological distress in cervical cancer screening: results from a German online survey. Archives of Gynecology and Obstetrics, 3/2020, 699-705.

 

Picture: Image Point Fr / Shutterstock.com