Medicap® · History & Innovation

BIOfibre®

A Century of Research in Artificial Hair Restoration Medicine — From Concept to CE MDR Certified Device

1913 The Idea
10 Milestones
2026 Ongoing
Explore the story

90 Years of Relentless Innovation

From a visionary concept in the early 20th century to a globally recognised medical device, the story of Biofibre is one of scientific perseverance, regulatory rigour, and transformative patient care. Click any milestone to explore in depth.

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1913
The First Patent — Method of Embedding Artificial Hair

The earliest known patent for embedding artificial hair into the human scalp — the first formal, legally recognised attempt to describe this technique. Patented April 22, 1913.

First Patent 1913 Pioneering

The earliest recorded intellectual property on the concept of artificial hair implantation dates to April 22, 1913. The patent — "Method of Embedding Artificial Hair" — represents the first formal, legally recognised attempt to describe a surgical technique for embedding artificial hair directly into the human scalp.

This pioneering document predated by decades the clinical experimentation of the 1970s and the biocompatible breakthroughs of the 1990s that would eventually give rise to Biofibre.

📍 The existence of this 1913 patent demonstrates that the desire to restore hair through artificial means is over a century old — and that the journey from concept to CE MDR-certified medical device spans more than 110 years of human ingenuity.
1913
The first patent
The Idea
1930
The First Medical Report — Hairshaft Implantation Method

A pioneering medical report documents the first "hairshaft implantation method" for treating baldness — the manual insertion of cut human hair shafts into the scalp.

First Report Hair Implantation Pioneering

In 1930, a pioneering medical report described a "hairshaft implantation method" for treating baldness — one of the earliest documented experiments in artificial hair implantation, long before the modern evolution of the field in the 1970s.

  • Historical Significance: Recognised as one of the earliest documented experiments in artificial or synthetic hair implantation.
  • Technical Concept: The method focused on the manual insertion of hair shafts directly into the skin — revolutionary for its time, yet different from modern techniques which involve living hair follicles rather than inert shafts.
📍 Context: This early work laid the intellectual groundwork for decades of future research, demonstrating that the desire to restore hair through implantation had already entered medical thinking decades before biomaterials science existed.
1930
First medical report
Re-start and Spread
'70s
The '70s — A Decade of Promise and Problems

The 1970s saw a surge of interest in artificial hair implantation worldwide — but inadequate materials, untested fibres, and unregulated practices led to widespread complications.

Controversy Unregulated Risk

The technique gained significant momentum during the 1970s, attracting growing attention from both the medical community and the commercial market. New methods were presented and debated at international medical meetings, marking a turning point in the field.

However, fierce competition — particularly in the North American market — led a number of companies to offer inadequately tested fibres for human hair replacement, often with very negative results. The race to commercialise outpaced the science.

Making matters worse, the technique was frequently being performed by non-medical operators, in non-medical environments, and without any standardised protocol. This opened the door to frequent and serious complications.

📍 The failures of the 1970s were not inevitable — they were the result of commercialisation without clinical rigour. Paradoxically, this difficult decade became the catalyst for the safety standards and biocompatible materials that would define Biofibre in the decades ahead.
'70s
Global revival
US Problems 1980
1983
US Problems — Regulatory Setback

The FDA raises serious concerns. High adverse event rates lead to an effective US ban in 1983, forcing the industry to prioritise safety above speed.

FDA Safety Regulation

In 1983, the FDA effectively banned artificial hair fibre implantation in the US. This shifted research focus to Europe and prompted scientists to develop genuinely biocompatible materials — setting the stage for the Biofibre breakthrough.

📍 Context: The FDA's strict stance forced the industry to prioritise safety and material science over speed to market — ultimately benefiting patients and directing innovation towards what would become Biofibre.
1983
The crisis that changed everything
Biofibre 1st Generation 1993
From 1990 Onwards
Biofibre 1st Generation — From Controversy to Medical Innovation: A New Era Begins

Italian researchers introduce Biofibre: a revolutionary biocompatible polyamide fibre with a patented single-use implanter. Clinical trials show dramatically lower rejection rates.

Italy Made in Italy Breakthrough

The early 1990s underwent a critical transition in the field of artificial hair implants. This period was defined by a shift from the dangerous practices of the 1980s to the establishment of rigorous medical protocols — a "scientific rehabilitation" to prove that artificial fibres could be safe if engineered correctly.

Development of Medical-Grade Polyamide (1991–1995): Between 1991 and 1993, pioneering research — notably by Medicap in Italy — led to the creation of the first biocompatible polyamide fibres. Unlike the industrial materials used previously, these new fibres were:

  • Chemically Inert: Designed specifically not to trigger an immune response or foreign-body rejection.
  • Structurally Advanced: Featuring a specialised "root loop" (knot) that allowed scalp tissue to stabilise around the fibre, preventing bacterial entry.

Establishment of Safety Protocols: The focus shifted from simple aesthetics to clinical safety. This era introduced the Mandatory Tolerance Test — a protocol where a small number of fibres were implanted and monitored for several weeks, allowing doctors to identify sensitive patients before a full implant. A safety measure that did not exist in the 1980s.

📍 In summary, the early 1990s served as the "clinical laboratory" that transformed a risky cosmetic trick into a controlled medical procedure, laying the technical foundation for the official EU recognition in 1996.
From 1990
Onwards
The Italian revolution
CE/TGA Approval
1995
CE Approval / TGA Listing — Medical Device Certified

Dual regulatory certification: CE Mark (EU) and TGA Listing (Australia). Biofibre becomes a legitimate, safe, regulated medical procedure worldwide.

🇪🇺 CE Mark 🇦🇺 TGA Certification

In 1995, Biofibre received dual regulatory approval as a certified medical device:

  • 🇪🇺 CE Mark (European Conformity) — confirming compliance with EU safety, health, and environmental standards
  • 🇦🇺 TGA Listing (Therapeutic Goods Administration, Australia)

This milestone legitimised Biofibre as a safe, regulated medical procedure — distinguishing it from the unregulated implants that had caused harm in earlier decades.

📍 Context: Medical device regulation in the 1990s was tightening globally. The dual certification opened access to thousands of patients across Europe and Australia, supported by trained medical networks.
1995
Global legitimacy
Medical Selection
2003
Biofibre Medical Selection — Standardising Patient Care

A formalised patient selection protocol is introduced. Biofibre transitions from "innovative procedure" to "clinical discipline" with evidence-based guidelines.

Protocols Evidence-Based Training

By 2003, clinical experience had accumulated across thousands of patients. Biofibre introduced a formalised patient selection protocol to maximise outcomes:

  • Trichoscopic evaluation to assess scalp health and alopecia type
  • Exclusion criteria defined for patients with autoimmune conditions or active scalp disease
  • Standardised pre/post-operative protocols to minimise infection risk
  • Training programmes for certifying surgeons and medical staff

Long-term follow-up studies demonstrated stable results in appropriately selected patients — reinforcing safety and efficacy data.

📍 Context: Evidence-based medicine was transforming all surgical disciplines. Biofibre aligned with this movement by introducing rigorous selection criteria, moving the procedure from art to science.
2003
Evidence-based medicine
Biofibre Evolution
2010
Biofibre Evolution — Next Generation Technology

A comprehensive upgrade across every system component: new surface micro-architecture, enhanced implanter ergonomics.

Next-Gen More Shades Integration

The 2010 Evolution represented a comprehensive upgrade across every component of the Biofibre system:

  • New surface micro-architecture improving tissue integration
  • Expanded colour palette
  • Compatibility with new hair care protocols and topical products
  • Updated implanter design for improved surgical ergonomics
📍 Context: 2010 marked an era of personalisation in aesthetic medicine. Ethnic diversity in the colour range reflected growing global demand for inclusive treatments.
2010
The great evolution
Automatic Implant 2013
2013
Automatic Implant of Biofibre — The Robot Era

The Automatic Biofibre Implanter arrives: motorised mechanism, consistent insertion depth and angle, faster sessions. Robotics enters hair restoration surgery.

Robotics Automation Precision

2013 marked the introduction of the Automatic Biofibre Implanter — a semi-automated device that dramatically improved procedure precision and efficiency.

  • Motorised implantation mechanism reducing hand fatigue in long sessions
  • Consistent insertion depth and angle across all fibres
  • Faster session times, enabling larger implantation areas per visit
  • Reduced risk of fibre trauma during placement
📍 Context: 2013 was the era of robotics entering surgery — from ROBODOC in orthopaedics to ARTAS in hair transplantation. Biofibre aligned with this technological wave.
2013
Robotic precision
Biofibre 4.0 2021
2021
Biofibre 4.0 — The Ultimate Generation of Biocompatible Fibres for Baldness

4th-generation fibre with enhanced biocompatibility and improved mechanical resistance — the most advanced solution for male and female alopecia.

4th Generation Biocompatibility 4.0 Alopecia

Biofibre 4.0 is the ultimate generation of biocompatible fibres for baldness — the result of decades of research, clinical experience, and continuous material innovation.

  • 🔬 4th-generation fibre with enhanced biocompatibility and improved mechanical resistance
  • 🌍 Expanded international clinical network across Europe, Asia-Pacific, and Latin America
📍 Context: Biofibre 4.0 positions artificial hair implantation as a fully integrated, modern medical-aesthetic procedure — designed to complement and enhance follicular unit transplantation (FUT/FUE) rather than replace it.
2021
Artificial intelligence era
2026 Ongoing
2026
ONGOING

Ongoing research aiming at perfecting the technique.

Research Innovation Future

The story of Biofibre is far from over. Dedicated research programmes continue to push the boundaries of artificial hair implantation, refining materials, techniques, and clinical protocols to deliver ever-better outcomes for patients worldwide. Nowadays Medicap's biocompatible fibres can be combined with all the existing medically recognised treatments for alopecia.

📍 Every milestone in this timeline was once a research goal. The next breakthrough is already underway.
2026
Ongoing
2026

2026 — Ongoing

The Story Is Not Finished

From a visionary concept in 1930 to a CE MDR-certified medical device used worldwide, Biofibre represents one of the most remarkable journeys in cosmetic medicine. Each decade brought new challenges — and new solutions.

medicaphair.com  ·  Medicap® Srl — CE 0373 Certified Medical Device

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